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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 90311

9 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
June 08, 2022
Product types
Device
Classifications
Class I
Statuses
Ongoing
Recalling firm wording
Covidien Llc

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

9 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 9

Palindrome Precision Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for acute and chronic hemodialysis, apheresis, and infusion.

Z-1312-2022
Recall number
Z-1312-2022
Initiated
June 08, 2022
Classification
Class I
Status
Ongoing
Recalling firm
Covidien Llc
Quantity
213,589 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-lumen void in the hub component, which may result in unanticipated fluid return during use.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-lumen void in the hub component, which may result in unanticipated fluid return during use.

Code information

Code Information organized as "Model No., Serial No., GTIN": 8888123400, 1729700111, 20884521012933; 8888123400, 1831000130, 20884521012933; 8888123400, 1904600085, 20884521012933; 8888133500, 2012100128, 20884521013060; 8888119360P, 2007800129, 10884521157699; 8888119360P, 2034400078, 10884521157699; 8888119360P, 1720000102, 20884521157696; 8888119360P, 1904200103, 20884521157696; 8888119360P, 1923400228, 20884521157696; 8888119360P, 1932300203, 20884521157696; 8888119360P, 2007800129, 20884521157696; 8888119360P, 2034400078, 20884521157696; 8888119360P, 2104600179, 20884521157696; 8888119360P, 2110900110, 20884521157696; 8888119360P, 2113300438, 20884521157696; 8888119360P, 2127700068, 20884521157696; 8888119364P, 1925200093, 10884521157705; 8888119364P, 1934400186, 10884521157705; 8888119364P, 2019500171, 10884521157705; 8888119364P, 2020400088, 10884521157705; 8888119364P, 2028200217, 10884521157705; 8888119364P, 2034400079, 10884521157705; 8888119364P, 2034400115, 10884521157705; 8888119364P, 2034400123, 10884521157705; 8888119364P, 2104600111, 10884521157705; 8888119364P, 2119300075, 10884521157705; 8888119364P, 2119700074, 10884521157705; 8888119364P, 1832300117, 20884521157702; 8888119364P, 1914800155, 20884521157702; 8888119364P, 1914800159, 20884521157702; 8888119364P, 1914800160, 20884521157702; 8888119364P, 1917200272, 20884521157702; 8888119364P, 1921300039, 20884521157702; 8888119364P, 1921300040, 20884521157702; 8888119364P, 1925200092, 20884521157702; 8888119364P, 1925200093, 20884521157702; 8888119364P, 1927300069, 20884521157702; 8888119364P, 1934400185, 20884521157702; 8888119364P, 1934400186, 20884521157702; 8888119364P, 2001400079, 20884521157702; 8888119364P, 2002100127, 20884521157702; 8888119364P, 2003100105, 20884521157702; 8888119364P, 2003100106, 20884521157702; 8888119364P, 2003100107, 20884521157702; 8888119364P, 2019500171, 20884521157702; 8888119364P, 2020400088, 20884521157702; 8888119364P, 2020400089, 20884521157702; 8888119364P, 2023300159, 20884521157702; 8888119364P, 2027200226, 20884521157702; 8888119364P, 2028200217, 20884521157702; 8888119364P, 2031800142, 20884521157702; 8888119364P, 2034400079, 20884521157702; 8888119364P, 2034400087, 20884521157702; 8888119364P, 2034400115, 20884521157702; 8888119364P, 2034400123, 20884521157702; 8888119364P, 2104600111, 20884521157702; 8888119364P, 2104600167, 20884521157702; 8888119364P, 2104600237, 20884521157702; 8888119364P, 2106900097, 20884521157702; 8888119364P, 2110900095, 20884521157702; 8888119364P, 2113300439, 20884521157702; 8888119364P, 2119300075, 20884521157702; 8888119364P, 2119700074, 20884521157702; 8888119364P, 2119700083, 20884521157702; 8888119364P, 2119700093, 20884521157702; 8888119364P, 2119700104, 20884521157702; 8888119364P, 2127200412, 20884521157702; 8888119370P, 1814300198, 20884521157740; 8888119370P, 1915800108, 20884521157740; 8888119370P, 2019500268, 20884521157740; 8888119370P, 2034400116, 20884521157740; 8888123400P, 1825400108, 20884521157764; 8888123400P, 1831600198, 20884521157764; 8888123400P, 1917200273, 20884521157764; 8888123400P, 1923400230, 20884521157764; 8888123400P, 2002100128, 20884521157764; 8888123400P, 2009300079, 20884521157764; 8888123400P, 2026000063, 20884521157764; 8888123400P, 2034400105, 20884521157764; 8888123400P, 2104600243, 20884521157764; 8888123400P, 2106900108, 20884521157764; 8888123400P, 2113400073, 20884521157764; 8888123400P, 2119700079, 20884521157764; 8888123400P, 2119700098, 20884521157764; 8888123404P, 2002100129, 10884521157774; 8888123404P, 2009300026, 10884521157774; 8888123404P, 2023300162, 10884521157774; 8888123404P, 2034400117, 10884521157774; 8888123404P, 2034400147, 10884521157774; 8888123404P, 2104600180, 10884521157774; 8888123404P, 2104600244, 10884521157774; 8888123404P, 2106900116, 10884521157774; 8888123404P, 2119300074, 10884521157774; 8888123404P, 2119700076, 10884521157774; 8888123404P, 2119700105, 10884521157774; 8888123404P, 2203800225, 10884521157774; 8888123404P, 1908400326, 20884521157771; 8888123404P, 1908400327, 20884521157771; 8888123404P, 1917600123, 20884521157771; 8888123404P, 1917600124, 20884521157771; 8888123404P, 1921900212, 20884521157771; 8888123404P, 1921900213, 20884521157771; 8888123404P, 1921900214, 20884521157771; 8888123404P, 1925200094, 20884521157771; 8888123404P, 1928800226, 20884521157771; 8888123404P, 1934400187, 20884521157771; 8888123404P, 1934400188, 20884521157771; 8888123404P, 2001400082, 20884521157771; 8888123404P, 2002100129, 20884521157771; 8888123404P, 2002900119, 20884521157771; 8888123404P, 2009300025, 20884521157771; 8888123404P, 2009300026, 20884521157771; 8888123404P, 2016000072, 20884521157771; 8888123404P, 2021000084, 20884521157771; 8888123404P, 2023300127, 20884521157771; 8888123404P, 2023300162, 20884521157771; 8888123404P, 2027200224, 20884521157771; 8888123404P, 2028200201, 20884521157771; 8888123404P, 2031800137, 20884521157771; 8888123404P, 2034400080, 20884521157771; 8888123404P, 2034400095, 20884521157771; 8888123404P, 2034400117, 20884521157771; 8888123404P, 2034400147, 20884521157771; 8888123404P, 2104600180, 20884521157771; 8888123404P, 2104600244, 20884521157771; 8888123404P, 2106900116, 20884521157771; 8888123404P, 2110900144, 20884521157771; 8888123404P, 2119300073, 20884521157771; 8888123404P, 2119300074, 20884521157771; 8888123404P, 2119600023, 20884521157771; 8888123404P, 2119600058, 20884521157771; 8888123404P, 2119700076, 20884521157771; 8888123404P, 2119700080, 20884521157771; 8888123404P, 2119700105, 20884521157771; 8888123404P, 2127200426, 20884521157771; 8888123404P, 2203800225, 20884521157771; 8888123410P, 2002100130, 10884521157811; 8888123410P, 2021000085, 10884521157811; 8888123410P, 1727100079, 20884521157818; 8888123410P, 1817700208, 20884521157818; 8888123410P, 1905600119, 20884521157818; 8888123410P, 2002100130, 20884521157818; 8888123410P, 2009300080, 20884521157818; 8888123410P, 2021000085, 20884521157818; 8888123410P, 2023300128, 20884521157818; 8888123410P, 2027200255, 20884521157818; 8888123410P, 2116900115, 20884521157818; 8888128450P, 1721300143, 20884521157832; 8888128450P, 1727700145, 20884521157832; 8888128450P, 1917600140, 20884521157832; 8888128450P, 2104100107, 20884521157832; 8888128450P, 2127200432, 20884521157832; 8888128454P, 2007800077, 10884521157842; 8888128454P, 2034400118, 10884521157842; 8888128454P, 2119600123, 10884521157842; 8888128454P, 1827600135, 20884521157849; 8888128454P, 1833100108, 20884521157849; 8888128454P, 1913000184, 20884521157849; 8888128454P, 1915800087, 20884521157849; 8888128454P, 1923400227, 20884521157849; 8888128454P, 1925200096, 20884521157849; 8888128454P, 2002100131, 20884521157849; 8888128454P, 2007800077, 20884521157849; 8888128454P, 2027200248, 20884521157849; 8888128454P, 2034400118, 20884521157849; 8888128454P, 2110900053, 20884521157849; 8888128454P, 2119600123, 20884521157849; 8888128454P, 2119700077, 20884521157849; 8888128454P, 2119700094, 20884521157849; 8888128460P, 1916500102, 20884521157887; 8888128460P, 1924000183, 20884521157887; 8888133500P, 1733300151, 20884521157900; 8888133504P, 1908400330, 10884521157910; 8888133504P, 2106900190, 10884521157910; 8888133504P, 1908400330, 20884521157917; 8888133504P, 1930900101, 20884521157917; 8888133504P, 2009300083, 20884521157917; 8888133504P, 2106900190, 20884521157917; 8888133504P, 2124600197, 20884521157917; 8888133510P, 2034400081, 20884521157955; 8888145014P, 1717900137, 10884521157972; 8888145014P, 1729100119, 10884521157972; 8888145014P, 1805900121, 10884521157972; 8888145014P, 1813600099, 10884521157972; 8888145014P, 1902800142, 10884521157972; 8888145014P, 1906700173, 10884521157972; 8888145014P, 1906700174, 10884521157972; 8888145014P, 1906700177, 10884521157972; 8888145014P, 1908400331, 10884521157972; 8888145014P, 1910600260, 10884521157972; 8888145014P, 1913000198, 10884521157972; 8888145014P, 1916500103, 10884521157972; 8888145014P, 1917200283, 10884521157972; 8888145014P, 1917200284, 10884521157972; 8888145014P, 1917200285, 10884521157972; 8888145014P, 1921300028, 10884521157972; 8888145014P, 1923400215, 10884521157972; 8888145014P, 2019500271, 10884521157972; 8888145014P, 2110900147, 10884521157972; 8888145014P, 2119700088, 10884521157972; 8888145014P, 2125800098, 10884521157972; 8888145014P, 1715800123, 20884521157979; 8888145014P, 1717900137, 20884521157979; 8888145014P, 1729100119, 20884521157979; 8888145014P, 1805900121, 20884521157979; 8888145014P, 1813600099, 20884521157979; 8888145014P, 1829500125, 20884521157979; 8888145014P, 1831000104, 20884521157979; 8888145014P, 1901400126, 20884521157979; 8888145014P, 1902800142, 20884521157979; 8888145014P, 1906700173, 20884521157979; 8888145014P, 1906700174, 20884521157979; 8888145014P, 1906700177, 20884521157979; 8888145014P, 1908400331, 20884521157979; 8888145014P, 1910600260, 20884521157979; 8888145014P, 1913000198, 20884521157979; 8888145014P, 1916500103, 20884521157979; 8888145014P, 1917200283, 20884521157979; 8888145014P, 1917200284, 20884521157979; 8888145014P, 1917200285, 20884521157979; 8888145014P, 1921300028, 20884521157979; 8888145014P, 1923400215, 20884521157979; 8888145014P, 2019500271, 20884521157979; 8888145014P, 2022000045, 20884521157979; 8888145014P, 2028200198, 20884521157979; 8888145014P, 2104100108, 20884521157979; 8888145014P, 2110900147, 20884521157979; 8888145014P, 2113300435, 20884521157979; 8888145014P, 2119700088, 20884521157979; 8888145014P, 2125800098, 20884521157979; 8888145014P, 2127200477, 20884521157979; 8888145014P, 2127200478, 20884521157979; 8888145015P, 1717900198, 10884521157989; 8888145015P, 1728200083, 10884521157989; 8888145015P, 1733700132, 10884521157989; 8888145015P, 1801700121, 10884521157989; 8888145015P, 1815000188, 10884521157989; 8888145015P, 1815800084, 10884521157989; 8888145015P, 1822000080, 10884521157989; 8888145015P, 1824700106, 10884521157989; 8888145015P, 1826200164, 10884521157989; 8888145015P, 1827600138, 10884521157989; 8888145015P, 1828200127, 10884521157989; 8888145015P, 1829500124, 10884521157989; 8888145015P, 1911500090, 10884521157989; 8888145015P, 1916500087, 10884521157989; 8888145015P, 1916500088, 10884521157989; 8888145015P, 1917600141, 10884521157989; 8888145015P, 1924000145, 10884521157989; 8888145015P, 1924000147, 10884521157989; 8888145015P, 2001400116, 10884521157989; 8888145015P, 2004400082, 10884521157989; 8888145015P, 2007800076, 10884521157989; 8888145015P, 2023300129, 10884521157989; 8888145015P, 2027200217, 10884521157989; 8888145015P, 2034400129, 10884521157989; 8888145015P, 2104100109, 10884521157989; 8888145015P, 2104600181, 10884521157989; 8888145015P, 2110900141, 10884521157989; 8888145015P, 2113400089, 10884521157989; 8888145015P, 2119700099, 10884521157989; 8888145015P, 2125800095, 10884521157989; 8888145015P, 1716500187, 20884521157986; 8888145015P, 1717900198, 20884521157986; 8888145015P, 1728200083, 20884521157986; 8888145015P, 1733700132, 20884521157986; 8888145015P, 1801700121, 20884521157986; 8888145015P, 1815000188, 20884521157986; 8888145015P, 1815800084, 20884521157986; 8888145015P, 1822000080, 20884521157986; 8888145015P, 1824700106, 20884521157986; 8888145015P, 1826200164, 20884521157986; 8888145015P, 1826800142, 20884521157986; 8888145015P, 1827600138, 20884521157986; 8888145015P, 1828200127, 20884521157986; 8888145015P, 1829500124, 20884521157986; 8888145015P, 1831000106, 20884521157986; 8888145015P, 1906000145, 20884521157986; 8888145015P, 1908400332, 20884521157986; 8888145015P, 1911500090, 20884521157986; 8888145015P, 1916500087, 20884521157986; 8888145015P, 1916500088, 20884521157986; 8888145015P, 1917600141, 20884521157986; 8888145015P, 1924000145, 20884521157986; 8888145015P, 1924000147, 20884521157986; 8888145015P, 2001400116, 20884521157986; 8888145015P, 2004400082, 20884521157986; 8888145015P, 2007800076, 20884521157986; 8888145015P, 2019500277, 20884521157986; 8888145015P, 2023300129, 20884521157986; 8888145015P, 2027200217, 20884521157986; 8888145015P, 2028200195, 20884521157986; 8888145015P, 2034400129, 20884521157986; 8888145015P, 2104100109, 20884521157986; 8888145015P, 2104600181, 20884521157986; 8888145015P, 2110900141, 20884521157986; 8888145015P, 2110900142, 20884521157986; 8888145015P, 2113400089, 20884521157986; 8888145015P, 2119700099, 20884521157986; 8888145015P, 2125800095, 20884521157986; 8888145015P, 2125800096, 20884521157986; 8888145015P, 2127200495, 20884521157986; 8888145015P, 2127200496, 20884521157986; 8888145016P, 1730500120, 10884521157996; 8888145016P, 1802400124, 10884521157996; 8888145016P, 1817100092, 10884521157996; 8888145016P, 1822000082, 10884521157996; 8888145016P, 1906700175, 10884521157996; 8888145016P, 1924000149, 10884521157996; 8888145016P, 2027200257, 10884521157996; 8888145016P, 2110900054, 10884521157996; 8888145016P, 2119700100, 10884521157996; 8888145016P, 1716500188, 20884521157993; 8888145016P, 1730500120, 20884521157993; 8888145016P, 1802400124, 20884521157993; 8888145016P, 1815000189, 20884521157993; 8888145016P, 1817100092, 20884521157993; 8888145016P, 1822000082, 20884521157993; 8888145016P, 1831000131, 20884521157993; 8888145016P, 1905600109, 20884521157993; 8888145016P, 1906700175, 20884521157993; 8888145016P, 1908800159, 20884521157993; 8888145016P, 1917600116, 20884521157993; 8888145016P, 1924000149, 20884521157993; 8888145016P, 2001400117, 20884521157993; 8888145016P, 2007800080, 20884521157993; 8888145016P, 2023300160, 20884521157993; 8888145016P, 2027200257, 20884521157993; 8888145016P, 2034400106, 20884521157993; 8888145016P, 2104600105, 20884521157993; 8888145016P, 2110900054, 20884521157993; 8888145016P, 2113400077, 20884521157993; 8888145016P, 2119700100, 20884521157993; 8888145016P, 2124500094, 20884521157993; 8888145016P, 2125800097, 20884521157993; 8888145017P, 1716500189, 10884521158009; 8888145017P, 1730500121, 10884521158009; 8888145017P, 1801700122, 10884521158009; 8888145017P, 1906700176, 10884521158009; 8888145017P, 1914800211, 10884521158009; 8888145017P, 1916500121, 10884521158009; 8888145017P, 1916500122, 10884521158009; 8888145017P, 1715100161, 20884521158006; 8888145017P, 1716500189, 20884521158006; 8888145017P, 1730500121, 20884521158006; 8888145017P, 1801700122, 20884521158006; 8888145017P, 1906700176, 20884521158006; 8888145017P, 1914800211, 20884521158006; 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8888145041P, 1935100106, 10884521158047; 8888145041P, 1935100107, 10884521158047; 8888145041P, 2002100138, 10884521158047; 8888145041P, 2019500278, 10884521158047; 8888145041P, 2023300138, 10884521158047; 8888145041P, 2026000065, 10884521158047; 8888145041P, 2027200191, 10884521158047; 8888145041P, 2031800146, 10884521158047; 8888145041P, 2034400108, 10884521158047; 8888145041P, 2104600108, 10884521158047; 8888145041P, 2113400067, 10884521158047; 8888145041P, 2119700085, 10884521158047; 8888145041P, 2119700087, 10884521158047; 8888145041P, 2124500112, 10884521158047; 8888145041P, 1722300119, 20884521158044; 8888145041P, 1726300128, 20884521158044; 8888145041P, 1727700143, 20884521158044; 8888145041P, 1734000168, 20884521158044; 8888145041P, 1805900122, 20884521158044; 8888145041P, 1808600074, 20884521158044; 8888145041P, 1815000195, 20884521158044; 8888145041P, 1818500198, 20884521158044; 8888145041P, 1826800139, 20884521158044; 8888145041P, 1828900135, 20884521158044; 8888145041P, 1902100140, 20884521158044; 8888145041P, 1908400308, 20884521158044; 8888145041P, 1908800184, 20884521158044; 8888145041P, 1909400131, 20884521158044; 8888145041P, 1910600252, 20884521158044; 8888145041P, 1916500104, 20884521158044; 8888145041P, 1923400225, 20884521158044; 8888145041P, 1926100262, 20884521158044; 8888145041P, 1935100106, 20884521158044; 8888145041P, 1935100107, 20884521158044; 8888145041P, 2002100138, 20884521158044; 8888145041P, 2019500278, 20884521158044; 8888145041P, 2023300138, 20884521158044; 8888145041P, 2026000065, 20884521158044; 8888145041P, 2027200191, 20884521158044; 8888145041P, 2031800146, 20884521158044; 8888145041P, 2034400108, 20884521158044; 8888145041P, 2104600108, 20884521158044; 8888145041P, 2113400067, 20884521158044; 8888145041P, 2119700085, 20884521158044; 8888145041P, 2119700087, 20884521158044; 8888145041P, 2124500112, 20884521158044; 8888145041P, 2124500122, 20884521158044; 8888145041P, 2127200514, 20884521158044; 8888145042P, 1715100165, 10884521158054; 8888145042P, 1720000112, 10884521158054; 8888145042P, 1733300159, 10884521158054; 8888145042P, 1801700138, 10884521158054; 8888145042P, 1805900123, 10884521158054; 8888145042P, 1818500199, 10884521158054; 8888145042P, 1826800144, 10884521158054; 8888145042P, 1903500124, 10884521158054; 8888145042P, 1913000185, 10884521158054; 8888145042P, 1914800216, 10884521158054; 8888145042P, 1917600118, 10884521158054; 8888145042P, 1918300138, 10884521158054; 8888145042P, 1923400226, 10884521158054; 8888145042P, 1926100263, 10884521158054; 8888145042P, 2001400114, 10884521158054; 8888145042P, 2022000046, 10884521158054; 8888145042P, 2023300164, 10884521158054; 8888145042P, 2026000066, 10884521158054; 8888145042P, 2027200250, 10884521158054; 8888145042P, 2119600124, 10884521158054; 8888145042P, 2119700086, 10884521158054; 8888145042P, 2127200527, 10884521158054; 8888145042P, 1720000112, 20884

Distribution pattern

Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, DC, GU, & PR. The countries of Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belgium, Botswana, Brazil, Brunei Darussalam, Bulgaria, Cambodia, Canada, Canary Islands, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Faroe Islands, Finland, France, French Guiana, French Polynesia, Georgia, Germany, Ghana, Greece, Guatemala, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Islamic Republic of Iran, Ireland, Israel, Italy, Jamaica, Japan, Kenya, Republic of Korea, Kosovo, Kuwait, Lebanon, Luxembourg, Macao, Malaysia, Maldives, Malta, Mayotte, Mexico, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nicaragua, North Macedonia, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, San Marino, Saudi Arabia, Senegal, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Thailand, Trinidad And Tobago, Tunisia, Turkey, United Arab Emirates, United Kingdom, United States, Viet Nam, Virgin Islands, and Zimbabwe.

device · product 2 of 9

Palindrome Precision H Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for acute and chronic hemodialysis, apheresis, and infusion.

Z-1313-2022
Recall number
Z-1313-2022
Initiated
June 08, 2022
Classification
Class I
Status
Ongoing
Recalling firm
Covidien Llc
Quantity
26,675 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-lumen void in the hub component, which may result in unanticipated fluid return during use.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-lumen void in the hub component, which may result in unanticipated fluid return during use.

Code information

Code Information organized as "Model No., Serial No., GTIN": 8888119365P, 2119400168, 10884521157712; 8888119365P, 1923400245, 20884521157719; 8888119365P, 1923400268, 20884521157719; 8888119365P, 1935100114, 20884521157719; 8888119365P, 2002100145, 20884521157719; 8888119365P, 2002900148, 20884521157719; 8888119365P, 2020400090, 20884521157719; 8888119365P, 2023300173, 20884521157719; 8888119365P, 2026000162, 20884521157719; 8888119365P, 2031800126, 20884521157719; 8888119365P, 2034400186, 20884521157719; 8888119365P, 2104600103, 20884521157719; 8888119365P, 2104600233, 20884521157719; 8888119365P, 2108100057, 20884521157719; 8888119365P, 2116500094, 20884521157719; 8888119365P, 2116500095, 20884521157719; 8888119365P, 2119400168, 20884521157719; 8888119371P, 1935100115, 10884521157750; 8888123405P, 2002100146, 10884521157781; 8888123405P, 2014900155, 10884521157781; 8888123405P, 2104600162, 10884521157781; 8888123405P, 1924000136, 20884521157788; 8888123405P, 1924000157, 20884521157788; 8888123405P, 1927300064, 20884521157788; 8888123405P, 1928800238, 20884521157788; 8888123405P, 2002100146, 20884521157788; 8888123405P, 2014900155, 20884521157788; 8888123405P, 2023300174, 20884521157788; 8888123405P, 2026000173, 20884521157788; 8888123405P, 2028200162, 20884521157788; 8888123405P, 2104600162, 20884521157788; 8888123405P, 2106900134, 20884521157788; 8888123405P, 2115800062, 20884521157788; 8888123405P, 2115800093, 20884521157788; 8888123405P, 2119400133, 20884521157788; 8888123411P, 2119400128, 20884521157825; 8888128455P, 2002100148, 10884521157859; 8888128455P, 1924000181, 20884521157856; 8888128455P, 1927300066, 20884521157856; 8888128455P, 2002100148, 20884521157856; 8888128455P, 2104600164, 20884521157856; 8888128455P, 2127200433, 20884521157856; 8888128461P, 2012100186, 20884521157894; 8888133505P, 1924600127, 20884521157924; 8888145043CP, 1927500054, 10884521158061; 8888145043CP, 2021000087, 10884521158061; 8888145043CP, 2026000094, 10884521158061; 8888145043CP, 2026000166, 10884521158061; 8888145043CP, 2120000069, 10884521158061; 8888145043CP, 1927500053, 20884521158068; 8888145043CP, 1927500054, 20884521158068; 8888145043CP, 2021000087, 20884521158068; 8888145043CP, 2026000093, 20884521158068; 8888145043CP, 2026000094, 20884521158068; 8888145043CP, 2026000166, 20884521158068; 8888145043CP, 2028200155, 20884521158068; 8888145043CP, 2115800061, 20884521158068; 8888145043CP, 2120000069, 20884521158068; 8888145043P, 1917200199, 10884521158078; 8888145043P, 1917200200, 10884521158078; 8888145043P, 1917200201, 10884521158078; 8888145043P, 1917200280, 10884521158078; 8888145043P, 1917200281, 10884521158078; 8888145043P, 1917600109, 10884521158078; 8888145043P, 1917600110, 10884521158078; 8888145043P, 2028200184, 10884521158078; 8888145043P, 2028200227, 10884521158078; 8888145043P, 1917200199, 20884521158075; 8888145043P, 1917200200, 20884521158075; 8888145043P, 1917200201, 20884521158075; 8888145043P, 1917200280, 20884521158075; 8888145043P, 1917200281, 20884521158075; 8888145043P, 1917600109, 20884521158075; 8888145043P, 1917600110, 20884521158075; 8888145043P, 1921300033, 20884521158075; 8888145043P, 1921900180, 20884521158075; 8888145043P, 2028200184, 20884521158075; 8888145043P, 2028200227, 20884521158075; 8888145044CP, 1907800083, 10884521158085; 8888145044CP, 1927500061, 10884521158085; 8888145044CP, 1927500062, 10884521158085; 8888145044CP, 2023300154, 10884521158085; 8888145044CP, 2026000123, 10884521158085; 8888145044CP, 2026000124, 10884521158085; 8888145044CP, 2026000125, 10884521158085; 8888145044CP, 2026000169, 10884521158085; 8888145044CP, 2119400129, 10884521158085; 8888145044CP, 2119400144, 10884521158085; 8888145044CP, 2125800093, 10884521158085; 8888145044CP, 1907800083, 20884521158082; 8888145044CP, 1927500061, 20884521158082; 8888145044CP, 1927500062, 20884521158082; 8888145044CP, 1929400083, 20884521158082; 8888145044CP, 2014900162, 20884521158082; 8888145044CP, 2023300154, 20884521158082; 8888145044CP, 2026000123, 20884521158082; 8888145044CP, 2026000124, 20884521158082; 8888145044CP, 2026000125, 20884521158082; 8888145044CP, 2026000132, 20884521158082; 8888145044CP, 2026000169, 20884521158082; 8888145044CP, 2119400129, 20884521158082; 8888145044CP, 2119400144, 20884521158082; 8888145044CP, 2125800093, 20884521158082; 8888145044P, 1917600112, 10884521158092; 8888145044P, 1917600113, 10884521158092; 8888145044P, 1917600114, 10884521158092; 8888145044P, 1917600115, 10884521158092; 8888145044P, 1917600135, 10884521158092; 8888145044P, 2023300137, 10884521158092; 8888145044P, 2026000174, 10884521158092; 8888145044P, 2028200164, 10884521158092; 8888145044P, 2028200187, 10884521158092; 8888145044P, 2106900214, 10884521158092; 8888145044P, 2106900227, 10884521158092; 8888145044P, 2124500093, 10884521158092; 8888145044P, 1917600112, 20884521158099; 8888145044P, 1917600113, 20884521158099; 8888145044P, 1917600114, 20884521158099; 8888145044P, 1917600115, 20884521158099; 8888145044P, 1917600135, 20884521158099; 8888145044P, 2023300137, 20884521158099; 8888145044P, 2026000174, 20884521158099; 8888145044P, 2028200164, 20884521158099; 8888145044P, 2028200187, 20884521158099; 8888145044P, 2106900214, 20884521158099; 8888145044P, 2106900227, 20884521158099; 8888145044P, 2124500093, 20884521158099; 8888145045CP, 1929400084, 10884521158108; 8888145045CP, 1929400085, 10884521158108; 8888145045CP, 2026000133, 10884521158108; 8888145045CP, 1929400084, 20884521158105; 8888145045CP, 1929400085, 20884521158105; 8888145045CP, 2026000133, 20884521158105; 8888145045CP, 2028200166, 20884521158105; 8888145045CP, 2119400136, 20884521158105; 8888145045CP, 2119400195, 20884521158105; 8888145045P, 1917200197, 10884521158115; 8888145045P, 1917200198, 10884521158115; 8888145045P, 2028200169, 10884521158115; 8888145045P, 2115800087, 10884521158115; 8888145045P, 2115800088, 10884521158115; 8888145045P, 1917200197, 20884521158112; 8888145045P, 1917200198, 20884521158112; 8888145045P, 2028200169, 20884521158112; 8888145045P, 2115800087, 20884521158112; 8888145045P, 2115800088, 20884521158112; 8888145046CP, 1924600100, 10884521158122; 8888145046CP, 1924600100, 20884521158129; 8888145046CP, 1926100280, 20884521158129; 8888145046CP, 1926800384, 20884521158129; 8888145046CP, 1929400094, 20884521158129; 8888145046CP, 2026000139, 20884521158129; 8888145046CP, 2028200167, 20884521158129; 8888145046P, 1916500094, 10884521158139; 8888145046P, 1916500095, 10884521158139; 8888145046P, 1920500226, 10884521158139; 8888145046P, 1921300030, 10884521158139; 8888145046P, 1916500094, 20884521158136; 8888145046P, 1916500095, 20884521158136; 8888145046P, 1921300030, 20884521158136; 8888145068P, 1934400183, 20884521158426; 8888145069P, 2104600231, 20884521158433; 8888145070P, 2026000172, 20884521158440; 8888145071P, 1922100139, 20884521158457

Distribution pattern

Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, DC, GU, & PR. The countries of Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belgium, Botswana, Brazil, Brunei Darussalam, Bulgaria, Cambodia, Canada, Canary Islands, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Faroe Islands, Finland, France, French Guiana, French Polynesia, Georgia, Germany, Ghana, Greece, Guatemala, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Islamic Republic of Iran, Ireland, Israel, Italy, Jamaica, Japan, Kenya, Republic of Korea, Kosovo, Kuwait, Lebanon, Luxembourg, Macao, Malaysia, Maldives, Malta, Mayotte, Mexico, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nicaragua, North Macedonia, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, San Marino, Saudi Arabia, Senegal, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Thailand, Trinidad And Tobago, Tunisia, Turkey, United Arab Emirates, United Kingdom, United States, Viet Nam, Virgin Islands, and Zimbabwe.

device · product 3 of 9

Palindrome Precision SI Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for acute and chronic hemodialysis, apheresis, and infusion.

Z-1314-2022
Recall number
Z-1314-2022
Initiated
June 08, 2022
Classification
Class I
Status
Ongoing
Recalling firm
Covidien Llc
Quantity
2,462 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-lumen void in the hub component, which may result in unanticipated fluid return during use.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-lumen void in the hub component, which may result in unanticipated fluid return during use.

Code information

Code Information organized as "Model No., Serial No., GTIN": 8888119368, 1925200090, 20884521012841; 8888119368, 1933700094, 20884521012841; 8888119368, 2001400077, 20884521012841; 8888119368, 2026000056, 20884521012841; 8888123408, 2009400114, 20884521012957; 8888128458, 1935100068, 20884521013039; 8888133508, 2026000060, 20884521013107; 8888145062, 2031800153, 10884521013407; 8888145062, 1933700095, 20884521013404; 8888145062, 2009400116, 20884521013404; 8888145062, 2031800131, 20884521013404; 8888145062, 2031800153, 20884521013404; 8888145063, 2000700056, 20884521013428; 8888145063, 2009400113, 20884521013428; 8888145063, 2027200181, 20884521013428; 8888145064, 2030100077, 20884521013442; 8888145065, 2026000067, 20884521013466; 8888145066, 2011900104, 10884521013476; 8888145066, 2019500162, 10884521013476; 8888145066, 2011900104, 20884521013473; 8888145066, 2019500162, 20884521013473

Distribution pattern

Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, DC, GU, & PR. The countries of Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belgium, Botswana, Brazil, Brunei Darussalam, Bulgaria, Cambodia, Canada, Canary Islands, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Faroe Islands, Finland, France, French Guiana, French Polynesia, Georgia, Germany, Ghana, Greece, Guatemala, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Islamic Republic of Iran, Ireland, Israel, Italy, Jamaica, Japan, Kenya, Republic of Korea, Kosovo, Kuwait, Lebanon, Luxembourg, Macao, Malaysia, Maldives, Malta, Mayotte, Mexico, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nicaragua, North Macedonia, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, San Marino, Saudi Arabia, Senegal, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Thailand, Trinidad And Tobago, Tunisia, Turkey, United Arab Emirates, United Kingdom, United States, Viet Nam, Virgin Islands, and Zimbabwe.

device · product 4 of 9

Palindrome Precision HSI Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusion.

Z-1315-2022
Recall number
Z-1315-2022
Initiated
June 08, 2022
Classification
Class I
Status
Ongoing
Recalling firm
Covidien Llc
Quantity
25,765 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-lumen void in the hub component, which may result in unanticipated fluid return during use.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-lumen void in the hub component, which may result in unanticipated fluid return during use.

Code information

Code Information organized as "Model No., Serial No., GTIN": 8888119369P, 2031800118, 10884521157736; 8888119369P, 1914400127, 20884521157733; 8888119369P, 1914400128, 20884521157733; 8888119369P, 1933700096, 20884521157733; 8888119369P, 1934400105, 20884521157733; 8888119369P, 2001400076, 20884521157733; 8888119369P, 2005600026, 20884521157733; 8888119369P, 2012100180, 20884521157733; 8888119369P, 2012100187, 20884521157733; 8888119369P, 2017500127, 20884521157733; 8888119369P, 2021000082, 20884521157733; 8888119369P, 2026000164, 20884521157733; 8888119369P, 2028200156, 20884521157733; 8888119369P, 2028200165, 20884521157733; 8888119369P, 2028200185, 20884521157733; 8888119369P, 2028200226, 20884521157733; 8888119369P, 2031800118, 20884521157733; 8888119369P, 2104600161, 20884521157733; 8888119369P, 2104600257, 20884521157733; 8888119369P, 2108100059, 20884521157733; 8888119369P, 2116500097, 20884521157733; 8888119369P, 2116500133, 20884521157733; 8888119369P, 2116900110, 20884521157733; 8888119369P, 2119400169, 20884521157733; 8888123409P, 2127200429, 10884521157804; 8888123409P, 1933000049, 20884521157801; 8888123409P, 1933000050, 20884521157801; 8888123409P, 1933000051, 20884521157801; 8888123409P, 1933000052, 20884521157801; 8888123409P, 1935100072, 20884521157801; 8888123409P, 2006200068, 20884521157801; 8888123409P, 2026000165, 20884521157801; 8888123409P, 2028200163, 20884521157801; 8888123409P, 2028200186, 20884521157801; 8888123409P, 2102800056, 20884521157801; 8888123409P, 2104600163, 20884521157801; 8888123409P, 2115800092, 20884521157801; 8888123409P, 2116900111, 20884521157801; 8888123409P, 2127200429, 20884521157801; 8888128459P, 2002900118, 20884521157870; 8888128459P, 2006200067, 20884521157870; 8888128459P, 2014900161, 20884521157870; 8888128459P, 2115800060, 20884521157870; 8888133509P, 2000700058, 20884521157948; 8888133509P, 2028200224, 20884521157948; 8888145048CP, 2031800121, 10884521158146; 8888145048CP, 1929500065, 20884521158143; 8888145048CP, 2020400100, 20884521158143; 8888145048CP, 2020400101, 20884521158143; 8888145048CP, 2031800121, 20884521158143; 8888145048P, 1916500092, 10884521158153; 8888145048P, 1916500093, 10884521158153; 8888145048P, 2005200100, 10884521158153; 8888145048P, 2005200101, 10884521158153; 8888145048P, 2021000083, 10884521158153; 8888145048P, 2023400068, 10884521158153; 8888145048P, 2026000170, 10884521158153; 8888145048P, 2028200154, 10884521158153; 8888145048P, 2028200157, 10884521158153; 8888145048P, 2028200171, 10884521158153; 8888145048P, 2031800122, 10884521158153; 8888145048P, 2031800124, 10884521158153; 8888145048P, 2115800089, 10884521158153; 8888145048P, 2115800090, 10884521158153; 8888145048P, 2115800091, 10884521158153; 8888145048P, 2115800094, 10884521158153; 8888145048P, 2124500092, 10884521158153; 8888145048P, 2124500102, 10884521158153; 8888145048P, 2124600213, 10884521158153; 8888145048P, 2124600214, 10884521158153; 8888145048P, 1916500092, 20884521158150; 8888145048P, 1916500093, 20884521158150; 8888145048P, 2005200100, 20884521158150; 8888145048P, 2005200101, 20884521158150; 8888145048P, 2021000083, 20884521158150; 8888145048P, 2023400068, 20884521158150; 8888145048P, 2026000170, 20884521158150; 8888145048P, 2028200154, 20884521158150; 8888145048P, 2028200157, 20884521158150; 8888145048P, 2028200171, 20884521158150; 8888145048P, 2031800122, 20884521158150; 8888145048P, 2031800124, 20884521158150; 8888145048P, 2115800089, 20884521158150; 8888145048P, 2115800090, 20884521158150; 8888145048P, 2115800091, 20884521158150; 8888145048P, 2115800094, 20884521158150; 8888145048P, 2124500092, 20884521158150; 8888145048P, 2124500102, 20884521158150; 8888145048P, 2124600213, 20884521158150; 8888145048P, 2124600214, 20884521158150; 8888145049CP, 2031800125, 20884521158167; 8888145049P, 1915800104, 10884521158177; 8888145049P, 1915800105, 10884521158177; 8888145049P, 2000700059, 10884521158177; 8888145049P, 2009300137, 10884521158177; 8888145049P, 2028200159, 10884521158177; 8888145049P, 2034400183, 10884521158177; 8888145049P, 1915800104, 20884521158174; 8888145049P, 1915800105, 20884521158174; 8888145049P, 2000700059, 20884521158174; 8888145049P, 2009300137, 20884521158174; 8888145049P, 2028200159, 20884521158174; 8888145049P, 2034400183, 20884521158174; 8888145050P, 1914800222, 10884521158252; 8888145050P, 2000700060, 10884521158252; 8888145050P, 2009400108, 10884521158252; 8888145050P, 1914800222, 20884521158259; 8888145050P, 1915800086, 20884521158259; 8888145050P, 2000700060, 20884521158259; 8888145050P, 2009400108, 20884521158259; 8888145057CP, 2020400102, 10884521158269; 8888145057CP, 1929500066, 20884521158266; 8888145057CP, 2020400102, 20884521158266; 8888145057P, 1914800224, 10884521158276; 8888145057P, 1914800225, 10884521158276; 8888145057P, 1915800088, 10884521158276; 8888145057P, 1934400103, 10884521158276; 8888145057P, 1934400104, 10884521158276; 8888145057P, 2014900175, 10884521158276; 8888145057P, 2017500129, 10884521158276; 8888145057P, 2019500256, 10884521158276; 8888145057P, 2019500257, 10884521158276; 8888145057P, 2104600232, 10884521158276; 8888145057P, 2110900109, 10884521158276; 8888145057P, 2116500161, 10884521158276; 8888145057P, 2116900114, 10884521158276; 8888145057P, 2124500090, 10884521158276; 8888145057P, 2124600207, 10884521158276; 8888145057P, 2124600235, 10884521158276; 8888145057P, 1914800223, 20884521158273; 8888145057P, 1914800224, 20884521158273; 8888145057P, 1914800225, 20884521158273; 8888145057P, 1934400103, 20884521158273; 8888145057P, 1934400104, 20884521158273; 8888145057P, 2009200091, 20884521158273; 8888145057P, 2014900163, 20884521158273; 8888145057P, 2014900175, 20884521158273; 8888145057P, 2017500129, 20884521158273; 8888145057P, 2019500256, 20884521158273; 8888145057P, 2019500257, 20884521158273; 8888145057P, 2028200172, 20884521158273; 8888145057P, 2104600205, 20884521158273; 8888145057P, 2104600232, 20884521158273; 8888145057P, 2106900155, 20884521158273; 8888145057P, 2110900109, 20884521158273; 8888145057P, 2116500161, 20884521158273; 8888145057P, 2116900114, 20884521158273; 8888145057P, 2124500090, 20884521158273; 8888145057P, 2124600207, 20884521158273; 8888145057P, 2124600235, 20884521158273

Distribution pattern

Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, DC, GU, & PR. The countries of Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belgium, Botswana, Brazil, Brunei Darussalam, Bulgaria, Cambodia, Canada, Canary Islands, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Faroe Islands, Finland, France, French Guiana, French Polynesia, Georgia, Germany, Ghana, Greece, Guatemala, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Islamic Republic of Iran, Ireland, Israel, Italy, Jamaica, Japan, Kenya, Republic of Korea, Kosovo, Kuwait, Lebanon, Luxembourg, Macao, Malaysia, Maldives, Malta, Mayotte, Mexico, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nicaragua, North Macedonia, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, San Marino, Saudi Arabia, Senegal, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Thailand, Trinidad And Tobago, Tunisia, Turkey, United Arab Emirates, United Kingdom, United States, Viet Nam, Virgin Islands, and Zimbabwe.

device · product 5 of 9

Palindrome Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for acute and chronic hemodialysis, apheresis, and infusion.

Z-1316-2022
Recall number
Z-1316-2022
Initiated
June 08, 2022
Classification
Class I
Status
Ongoing
Recalling firm
Covidien Llc
Quantity
576,018 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-lumen void in the hub component, which may result in unanticipated fluid return during use.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-lumen void in the hub component, which may result in unanticipated fluid return during use.

Code information

Code Information organized as "Model No., Serial No., GTIN": 8888119360, 1916500132, 20884521012803; 8888119364, 1831000099, 20884521056555; 8888119364, 1832300114, 20884521056555; 8888119364, 2019500276, 20884521056555; 8888119364, 2106900226, 20884521056555; 8888123404, 1912600108, 20884521056586; 8888123404, 1934400172, 20884521056586; 8888123404, 2012100136, 20884521056586; 8888123404, 2017500130, 20884521056586; 8888123404, 2034400075, 20884521056586; 8888123404, 2104600236, 20884521056586; 8888123404, 2125800094, 20884521056586; 8888123404, 2127200415, 20884521056586; 8888123410, 2019500253, 20884521012988; 8888123410, 2104100079, 20884521012988; 8888128450, 2127200431, 20884521013008; 8888128454, 2017800061, 10884521056619; 8888128454, 1822600121, 20884521056616; 8888128454, 2017800061, 20884521056616; 8888128460, 2019500266, 20884521013053; 8888145014, 1715100153, 10884521013148; 8888145014, 1715800117, 10884521013148; 8888145014, 1715900177, 10884521013148; 8888145014, 1716100154, 10884521013148; 8888145014, 1717200138, 10884521013148; 8888145014, 1717400127, 10884521013148; 8888145014, 1717900133, 10884521013148; 8888145014, 1718600101, 10884521013148; 8888145014, 1719300100, 10884521013148; 8888145014, 1719800114, 10884521013148; 8888145014, 1720000100, 10884521013148; 8888145014, 1720700111, 10884521013148; 8888145014, 1721300160, 10884521013148; 8888145014, 1723400096, 10884521013148; 8888145014, 1724900105, 10884521013148; 8888145014, 1726300130, 10884521013148; 8888145014, 1726400083, 10884521013148; 8888145014, 1727100074, 10884521013148; 8888145014, 1728600063, 10884521013148; 8888145014, 1729700112, 10884521013148; 8888145014, 1731900212, 10884521013148; 8888145014, 1733300157, 10884521013148; 8888145014, 1733300163, 10884521013148; 8888145014, 1734700107, 10884521013148; 8888145014, 1800300139, 10884521013148; 8888145014, 1801000129, 10884521013148; 8888145014, 1801000130, 10884521013148; 8888145014, 1801700128, 10884521013148; 8888145014, 1804500149, 10884521013148; 8888145014, 1804500152, 10884521013148; 8888145014, 1804500153, 10884521013148; 8888145014, 1805200094, 10884521013148; 8888145014, 1805900132, 10884521013148; 8888145014, 1807300172, 10884521013148; 8888145014, 1807300173, 10884521013148; 8888145014, 1808600067, 10884521013148; 8888145014, 1809400139, 10884521013148; 8888145014, 1812200179, 10884521013148; 8888145014, 1812700099, 10884521013148; 8888145014, 1819000134, 10884521013148; 8888145014, 1819000143, 10884521013148; 8888145014, 1820700110, 10884521013148; 8888145014, 1820700112, 10884521013148; 8888145014, 1820700114, 10884521013148; 8888145014, 1821300120, 10884521013148; 8888145014, 1821300121, 10884521013148; 8888145014, 1821300122, 10884521013148; 8888145014, 1823400084, 10884521013148; 8888145014, 1823400087, 10884521013148; 8888145014, 1824700121, 10884521013148; 8888145014, 1827600136, 10884521013148; 8888145014, 1828200125, 10884521013148; 8888145014, 1829500108, 10884521013148; 8888145014, 1830300168, 10884521013148; 8888145014, 1830300169, 10884521013148; 8888145014, 1831600200, 10884521013148; 8888145014, 1832300111, 10884521013148; 8888145014, 1832300112, 10884521013148; 8888145014, 1833100110, 10884521013148; 8888145014, 1835100115, 10884521013148; 8888145014, 1835300233, 10884521013148; 8888145014, 1835300234, 10884521013148; 8888145014, 1835300235, 10884521013148; 8888145014, 1900700140, 10884521013148; 8888145014, 1900700142, 10884521013148; 8888145014, 1900700143, 10884521013148; 8888145014, 1900700144, 10884521013148; 8888145014, 1901400101, 10884521013148; 8888145014, 1902800139, 10884521013148; 8888145014, 1902800141, 10884521013148; 8888145014, 1903500106, 10884521013148; 8888145014, 1903500107, 10884521013148; 8888145014, 1904200095, 10884521013148; 8888145014, 1904900121, 10884521013148; 8888145014, 1904900123, 10884521013148; 8888145014, 1905600057, 10884521013148; 8888145014, 1905600125, 10884521013148; 8888145014, 1905600126, 10884521013148; 8888145014, 1906000129, 10884521013148; 8888145014, 1909400132, 10884521013148; 8888145014, 1910200091, 10884521013148; 8888145014, 1911500109, 10884521013148; 8888145014, 1911500110, 10884521013148; 8888145014, 1911500111, 10884521013148; 8888145014, 1911500112, 10884521013148; 8888145014, 1911500113, 10884521013148; 8888145014, 1912600100, 10884521013148; 8888145014, 1912600101, 10884521013148; 8888145014, 1912600102, 10884521013148; 8888145014, 1914000267, 10884521013148; 8888145014, 1914000270, 10884521013148; 8888145014, 1914000271, 10884521013148; 8888145014, 1914400141, 10884521013148; 8888145014, 1914400142, 10884521013148; 8888145014, 1914800172, 10884521013148; 8888145014, 1914800204, 10884521013148; 8888145014, 1915800096, 10884521013148; 8888145014, 1915800097, 10884521013148; 8888145014, 1915800098, 10884521013148; 8888145014, 1919700101, 10884521013148; 8888145014, 1919800096, 10884521013148; 8888145014, 1919800097, 10884521013148; 8888145014, 1919800098, 10884521013148; 8888145014, 1919800099, 10884521013148; 8888145014, 1919800109, 10884521013148; 8888145014, 1919800111, 10884521013148; 8888145014, 1921100180, 10884521013148; 8888145014, 1921100182, 10884521013148; 8888145014, 1922100141, 10884521013148; 8888145014, 1922500100, 10884521013148; 8888145014, 1922500101, 10884521013148; 8888145014, 1922500102, 10884521013148; 8888145014, 1922500103, 10884521013148; 8888145014, 1922500106, 10884521013148; 8888145014, 1922500199, 10884521013148; 8888145014, 1926100305, 10884521013148; 8888145014, 1926800390, 10884521013148; 8888145014, 1926800391, 10884521013148; 8888145014, 1926800392, 10884521013148; 8888145014, 1926800393, 10884521013148; 8888145014, 1927600099, 10884521013148; 8888145014, 1927600100, 10884521013148; 8888145014, 1928200085, 10884521013148; 8888145014, 1928800200, 10884521013148; 8888145014, 1928800201, 10884521013148; 8888145014, 1928800202, 10884521013148; 8888145014, 1928800205, 10884521013148; 8888145014, 1928800207, 10884521013148; 8888145014, 1928800246, 10884521013148; 8888145014, 1928800247, 10884521013148; 8888145014, 1928800248, 10884521013148; 8888145014, 1930200112, 10884521013148; 8888145014, 1930200114, 10884521013148; 8888145014, 1930400108, 10884521013148; 8888145014, 1930900092, 10884521013148; 8888145014, 1930900097, 10884521013148; 8888145014, 1930900099, 10884521013148; 8888145014, 1931600123, 10884521013148; 8888145014, 1931600127, 10884521013148; 8888145014, 1933700122, 10884521013148; 8888145014, 1933700123, 10884521013148; 8888145014, 1933700124, 10884521013148; 8888145014, 1934400139, 10884521013148; 8888145014, 1934400167, 10884521013148; 8888145014, 1934400168, 10884521013148; 8888145014, 1934400169, 10884521013148; 8888145014, 1934400170, 10884521013148; 8888145014, 2002100141, 10884521013148; 8888145014, 2008400124, 10884521013148; 8888145014, 2008500083, 10884521013148; 8888145014, 2008500085, 10884521013148; 8888145014, 2008500086, 10884521013148; 8888145014, 2012100129, 10884521013148; 8888145014, 2012100130, 10884521013148; 8888145014, 2012100131, 10884521013148; 8888145014, 2012100132, 10884521013148; 8888145014, 2012100133, 10884521013148; 8888145014, 2015100056, 10884521013148; 8888145014, 2016400033, 10884521013148; 8888145014, 2016400034, 10884521013148; 8888145014, 2019500255, 10884521013148; 8888145014, 2019500274, 10884521013148; 8888145014, 2019500279, 10884521013148; 8888145014, 2020400091, 10884521013148; 8888145014, 2020400092, 10884521013148; 8888145014, 2020400094, 10884521013148; 8888145014, 2020400095, 10884521013148; 8888145014, 2020400096, 10884521013148; 8888145014, 2020400097, 10884521013148; 8888145014, 2020400098, 10884521013148; 8888145014, 2023300123, 10884521013148; 8888145014, 2023300124, 10884521013148; 8888145014, 2023300148, 10884521013148; 8888145014, 2023300149, 10884521013148; 8888145014, 2023300156, 10884521013148; 8888145014, 2023300157, 10884521013148; 8888145014, 2028200219, 10884521013148; 8888145014, 2028200220, 10884521013148; 8888145014, 2028200221, 10884521013148; 8888145014, 2028200222, 10884521013148; 8888145014, 2028200223, 10884521013148; 8888145014, 2029600112, 10884521013148; 8888145014, 2029600113, 10884521013148; 8888145014, 2029600114, 10884521013148; 8888145014, 2029600115, 10884521013148; 8888145014, 2029600116, 10884521013148; 8888145014, 2031800147, 10884521013148; 8888145014, 2031800148, 10884521013148; 8888145014, 2031800149, 10884521013148; 8888145014, 2031800151, 10884521013148; 8888145014, 2031800152, 10884521013148; 8888145014, 2034400121, 10884521013148; 8888145014, 2034400137, 10884521013148; 8888145014, 2102500096, 10884521013148; 8888145014, 2102600119, 10884521013148; 8888145014, 2104100081, 10884521013148; 8888145014, 2104100082, 10884521013148; 8888145014, 2104100083, 10884521013148; 8888145014, 2104100096, 10884521013148; 8888145014, 2104100097, 10884521013148; 8888145014, 2104100098, 10884521013148; 8888145014, 2104100099, 10884521013148; 8888145014, 2104100100, 10884521013148; 8888145014, 2104600115, 10884521013148; 8888145014, 2104600165, 10884521013148; 8888145014, 2104600169, 10884521013148; 8888145014, 2104600240, 10884521013148; 8888145014, 2106900191, 10884521013148; 8888145014, 2106900192, 10884521013148; 8888145014, 2106900193, 10884521013148; 8888145014, 2106900194, 10884521013148; 8888145014, 2110900115, 10884521013148; 8888145014, 2110900155, 10884521013148; 8888145014, 2110900156, 10884521013148; 8888145014, 2113300442, 10884521013148; 8888145014, 2113300443, 10884521013148; 8888145014, 2113300444, 10884521013148; 8888145014, 2113300445, 10884521013148; 8888145014, 2113300446, 10884521013148; 8888145014, 2113400058, 10884521013148; 8888145014, 2113400064, 10884521013148; 8888145014, 2113400070, 10884521013148; 8888145014, 2113400082, 10884521013148; 8888145014, 2113400099, 10884521013148; 8888145014, 2116500091, 10884521013148; 8888145014, 2116500093, 10884521013148; 8888145014, 2116500125, 10884521013148; 8888145014, 2116500126, 10884521013148; 8888145014, 2116500127, 10884521013148; 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8888145015, 1911500115, 10884521013162; 8888145015, 1911500116, 10884521013162; 8888145015, 1912600103, 10884521013162; 8888145015, 1912600104, 10884521013162; 8888145015, 1912600105, 10884521013162; 8888145015, 1915800089, 10884521013162; 8888145015, 1915800090, 10884521013162; 8888145015, 1915800092, 10884521013162; 8888145015, 1917600088, 10884521013162; 8888145015, 1917700081, 10884521013162; 8888145015, 1917700082, 10884521013162; 8888145015, 1917700083, 10884521013162; 8888145015, 1917700084, 10884521013162; 8888145015, 1917700085, 10884521013162; 8888145015, 1919700104, 10884521013162; 8888145015, 1919700105, 10884521013162; 8888145015, 1919700106, 10884521013162; 8888145015, 1919700107, 10884521013162; 8888145015, 1919700108, 10884521013162; 8888145015, 1919800095, 10884521013162; 8888145015, 1922500099, 10884521013162; 8888145015, 1922500220, 10884521013162; 8888145015, 1922500221, 10884521013162; 8888145015, 1922500222, 10884521013162; 8888145015, 1922500223, 10884521013162; 8888145015, 1922500224, 10884521013162; 8888145015, 1922500225, 10884521013162; 8888145015, 1922500226, 10884521013162; 8888145015, 1926800394, 10884521013162; 8888145015, 1926800395, 10884521013162; 8888145015, 1926800396, 10884521013162; 8888145015, 1926800397, 10884521013162; 8888145015, 1926800398, 10884521013162; 8888145015, 1928800242, 10884521013162; 8888145015, 1929500114, 10884521013162; 8888145015, 1930200103, 10884521013162; 8888145015, 1930200104, 10884521013162; 8888145015, 1930200105, 10884521013162; 8888145015, 1930400106, 10884521013162; 8888145015, 1931500079, 10884521013162; 8888145015, 1931600121, 10884521013162; 8888145015, 1931600122, 10884521013162; 8888145015, 1932300198, 10884521013162; 8888145015, 1932300200, 10884521013162; 8888145015, 1932300201, 10884521013162; 8888145015, 1933800172, 10884521013162; 8888145015, 2000700088, 10884521013162; 8888145015, 2003700039, 10884521013162; 8888145015, 2003700045, 10884521013162; 8888145015, 2007000053, 10884521013162; 8888145015, 2007000054, 10884521013162; 8888145015, 2007000055, 10884521013162; 8888145015, 2007000056, 10884521013162; 8888145015, 2007000057, 10884521013162; 8888145015, 2012100125, 10884521013162; 8888145015, 2012100126, 10884521013162; 8888145015, 2012100127, 10884521013162; 8888145015, 2015100053, 10884521013162; 8888145015, 2015100054, 10884521013162; 8888145015, 2015100055, 10884521013162; 8888145015, 2016500072, 10884521013162; 8888145015, 2017100091, 10884521013162; 8888145015, 2018100025, 10884521013162; 8888145015, 2018100026, 10884521013162; 8888145015, 2018200029, 10884521013162; 8888145015, 2019100005, 10884521013162; 8888145015, 2019500273, 10884521013162; 8888145015, 2023300109, 10884521013162; 8888145015, 2023300146, 10884521013162; 8888145015, 2023300155, 10884521013162; 8888145015, 2027200210, 10884521013162; 8888145015, 2027200216, 10884521013162; 8888145015, 2028200190, 10884521013162; 8888145015, 2028200191, 10884521013162; 8888145015, 2028200192, 10884521013162; 8888145015, 2028200193, 10884521013162; 8888145015, 2028200199, 10884521013162; 8888145015, 2028200213, 10884521013162; 8888145015, 2031800127, 10884521013162; 8888145015, 2031800128, 10884521013162; 8888145015, 2034400085, 10884521013162; 8888145015, 2034400094, 10884521013162; 8888145015, 2034400099, 10884521013162; 8888145015, 2034400103, 10884521013162; 8888145015, 2034400110, 10884521013162; 8888145015, 2034400120, 10884521013162; 8888145015, 2034400132, 10884521013162; 8888145015, 2034400136, 10884521013162; 8888145015, 2104600168, 10884521013162; 8888145015, 2104600206, 10884521013162; 8888145015, 2104600210, 10884521013162; 8888145015, 2106900103, 10884521013162; 8888145015, 2106900182, 10884521013162; 8888145015, 2106900197, 10884521013162; 8888145015, 2106900229, 10884521013162; 8888145015, 2110900148, 10884521013162; 8888145015, 2110900154, 10884521013162; 8888145015, 2113400069, 10884521013162; 8888145015, 2113400080, 10884521013162; 8888145015, 2116600125, 10884521013162; 8888145015, 2116600162, 10884521013162; 8888145015, 2124500091, 10884521013162; 8888145015, 2124500097, 10884521013162; 8888145015, 2124500113, 10884521013162; 8888145015, 2124500115, 10884521013162; 8888145015, 2124500123, 10884521013162; 8888145015, 2124500124, 10884521013162; 8888145015, 2124600238, 10884521013162; 8888145015, 2124600246, 10884521013162; 8888145015, 2124600250, 10884521013162; 8888145015, 2124600251, 10884521013162; 8888145015, 2124600254, 10884521013162; 8888145015, 2124600257, 10884521013162; 8888145015, 2124600263, 10884521013162; 8888145015, 2124600264, 10884521013162; 8888145015, 2127200481, 10884521013162; 8888145015, 2200300056, 10884521013162; 8888145015, 2200300059, 10884521013162; 8888145015, 2201000060, 10884521013162; 8888145015, 2201000061, 10884521013162; 8888145015, 2201000063, 10884521013162; 8888145015, 1715100154, 20884521013169; 8888145015, 1715800118, 20884521013169; 8888145015, 1716300113, 20884521013169; 8888145015, 1716500176, 20884521013169; 8888145015, 1717600073, 20884521013169; 8888145015, 1717900134, 20884521013169; 8888145015, 1718600102, 20884521013169; 8888145015, 1719300101, 20884521013169; 8888145015, 1720100134, 20884521013169; 8888145015, 1720400112, 20884521013169; 8888145015, 1720700112, 20884521013169; 8888145015, 1721300142, 20884521013169; 8888145015, 1729700113, 20884521013169; 8888145015, 1730500135, 20884521013169; 8888145015, 1731200153, 20884521013169; 8888145015, 1731200181, 20884521013169; 8888145015, 1732600133, 20884521013169; 8888145015, 1732600135, 20884521013169; 8888145015, 1733300

Distribution pattern

Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, DC, GU, & PR. The countries of Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belgium, Botswana, Brazil, Brunei Darussalam, Bulgaria, Cambodia, Canada, Canary Islands, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Faroe Islands, Finland, France, French Guiana, French Polynesia, Georgia, Germany, Ghana, Greece, Guatemala, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Islamic Republic of Iran, Ireland, Israel, Italy, Jamaica, Japan, Kenya, Republic of Korea, Kosovo, Kuwait, Lebanon, Luxembourg, Macao, Malaysia, Maldives, Malta, Mayotte, Mexico, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nicaragua, North Macedonia, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, San Marino, Saudi Arabia, Senegal, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Thailand, Trinidad And Tobago, Tunisia, Turkey, United Arab Emirates, United Kingdom, United States, Viet Nam, Virgin Islands, and Zimbabwe.

device · product 6 of 9

Palindrome H Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusion.

Z-1317-2022
Recall number
Z-1317-2022
Initiated
June 08, 2022
Classification
Class I
Status
Ongoing
Recalling firm
Covidien Llc
Quantity
26,474 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-lumen void in the hub component, which may result in unanticipated fluid return during use.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-lumen void in the hub component, which may result in unanticipated fluid return during use.

Code information

Code Information organized as "Model No., Serial No., GTIN": 8888119365, 1925200097, 20884521012810; 8888119371, 2031800117, 20884521056562; 8888123405, 2028200168, 20884521012940; 8888123405, 2127200428, 20884521012940; 8888145043, 1932200082, 10884521013223; 8888145043, 2003700042, 10884521013223; 8888145043, 2014900147, 10884521013223; 8888145043, 2023300169, 10884521013223; 8888145043, 2031800113, 10884521013223; 8888145043, 2034400185, 10884521013223; 8888145043, 2104600104, 10884521013223; 8888145043, 2108100054, 10884521013223; 8888145043, 2127200539, 10884521013223; 8888145043, 1919700110, 20884521013220; 8888145043, 1929500076, 20884521013220; 8888145043, 1932200082, 20884521013220; 8888145043, 2000700103, 20884521013220; 8888145043, 2003700042, 20884521013220; 8888145043, 2014900147, 20884521013220; 8888145043, 2019200001, 20884521013220; 8888145043, 2023300169, 20884521013220; 8888145043, 2028200174, 20884521013220; 8888145043, 2031800112, 20884521013220; 8888145043, 2031800113, 20884521013220; 8888145043, 2034400185, 20884521013220; 8888145043, 2034400187, 20884521013220; 8888145043, 2104600100, 20884521013220; 8888145043, 2104600104, 20884521013220; 8888145043, 2108100054, 20884521013220; 8888145043, 2108100055, 20884521013220; 8888145043, 2108100056, 20884521013220; 8888145043, 2109700070, 20884521013220; 8888145043, 2116500163, 20884521013220; 8888145043, 2124500119, 20884521013220; 8888145043, 2127200539, 20884521013220; 8888145043, 2127200540, 20884521013220; 8888145043, 2127200541, 20884521013220; 8888145044, 1922500109, 10884521013247; 8888145044, 1922500112, 10884521013247; 8888145044, 1925200063, 10884521013247; 8888145044, 1933700119, 10884521013247; 8888145044, 2000700104, 10884521013247; 8888145044, 2104600101, 10884521013247; 8888145044, 2106900137, 10884521013247; 8888145044, 2110900104, 10884521013247; 8888145044, 2113400084, 10884521013247; 8888145044, 2116200117, 10884521013247; 8888145044, 2200300118, 10884521013247; 8888145044, 1922500109, 20884521013244; 8888145044, 1922500110, 20884521013244; 8888145044, 1922500112, 20884521013244; 8888145044, 1925200063, 20884521013244; 8888145044, 1929500075, 20884521013244; 8888145044, 1929500092, 20884521013244; 8888145044, 1933700119, 20884521013244; 8888145044, 2000700104, 20884521013244; 8888145044, 2104600101, 20884521013244; 8888145044, 2104600102, 20884521013244; 8888145044, 2104900109, 20884521013244; 8888145044, 2106900137, 20884521013244; 8888145044, 2110900104, 20884521013244; 8888145044, 2113300436, 20884521013244; 8888145044, 2113400084, 20884521013244; 8888145044, 2116200115, 20884521013244; 8888145044, 2116200116, 20884521013244; 8888145044, 2116200117, 20884521013244; 8888145044, 2124500106, 20884521013244; 8888145044, 2124500121, 20884521013244; 8888145044, 2200300118, 20884521013244; 8888145045, 1929500093, 10884521017900; 8888145045, 1933700120, 10884521017900; 8888145045, 2004400084, 10884521017900; 8888145045, 2110900143, 10884521017900; 8888145045, 2113400059, 10884521017900; 8888145045, 1822000073, 20884521017907; 8888145045, 1929500093, 20884521017907; 8888145045, 1933700120, 20884521017907; 8888145045, 2004400084, 20884521017907; 8888145045, 2110900143, 20884521017907; 8888145045, 2113400059, 20884521017907; 8888145045, 2124500087, 20884521017907; 8888145046, 1927500059, 20884521013268; 8888145046, 1927500060, 20884521013268; 8888145069, 2017600095, 20884521056708; 8888145070, 2026000154, 20884521056715; 8888145043C, 1924600101, 10884521056305; 8888145043C, 1926100282, 10884521056305; 8888145043C, 2002900150, 10884521056305; 8888145043C, 2014900156, 10884521056305; 8888145043C, 2017500125, 10884521056305; 8888145043C, 2017500128, 10884521056305; 8888145043C, 2017600093, 10884521056305; 8888145043C, 2026000077, 10884521056305; 8888145043C, 2026000079, 10884521056305; 8888145043C, 2026000080, 10884521056305; 8888145043C, 2026000081, 10884521056305; 8888145043C, 2116200114, 10884521056305; 8888145043C, 2119400127, 10884521056305; 8888145043C, 2125800084, 10884521056305; 8888145043C, 2125800085, 10884521056305; 8888145043C, 2125800086, 10884521056305; 8888145043C, 2125800087, 10884521056305; 8888145043C, 1924600101, 20884521056302; 8888145043C, 1926100282, 20884521056302; 8888145043C, 2002900150, 20884521056302; 8888145043C, 2014900156, 20884521056302; 8888145043C, 2017500125, 20884521056302; 8888145043C, 2017500128, 20884521056302; 8888145043C, 2017600093, 20884521056302; 8888145043C, 2026000077, 20884521056302; 8888145043C, 2026000079, 20884521056302; 8888145043C, 2026000080, 20884521056302; 8888145043C, 2026000081, 20884521056302; 8888145043C, 2116200114, 20884521056302; 8888145043C, 2119400127, 20884521056302; 8888145043C, 2125800086, 20884521056302; 8888145043C, 2125800087, 20884521056302; 8888145043C, 2125800088, 20884521056302; 8888145044C, 1924600102, 10884521056312; 8888145044C, 1926100278, 10884521056312; 8888145044C, 1926100283, 10884521056312; 8888145044C, 1926100284, 10884521056312; 8888145044C, 1928100093, 10884521056312; 8888145044C, 2014900157, 10884521056312; 8888145044C, 2017600094, 10884521056312; 8888145044C, 2023300171, 10884521056312; 8888145044C, 2026000082, 10884521056312; 8888145044C, 2026000083, 10884521056312; 8888145044C, 2026000084, 10884521056312; 8888145044C, 2026000085, 10884521056312; 8888145044C, 2026000086, 10884521056312; 8888145044C, 2026000153, 10884521056312; 8888145044C, 2106900135, 10884521056312; 8888145044C, 2106900213, 10884521056312; 8888145044C, 2108100058, 10884521056312; 8888145044C, 1924600102, 20884521056319; 8888145044C, 1926100278, 20884521056319; 8888145044C, 1926100283, 20884521056319; 8888145044C, 1926100284, 20884521056319; 8888145044C, 1928100093, 20884521056319; 8888145044C, 2014900157, 20884521056319; 8888145044C, 2017600094, 20884521056319; 8888145044C, 2023300171, 20884521056319; 8888145044C, 2026000082, 20884521056319; 8888145044C, 2026000084, 20884521056319; 8888145044C, 2026000085, 20884521056319; 8888145044C, 2026000086, 20884521056319; 8888145044C, 2026000153, 20884521056319; 8888145044C, 2106900135, 20884521056319; 8888145044C, 2106900140, 20884521056319; 8888145044C, 2106900213, 20884521056319; 8888145044C, 2108100058, 20884521056319; 8888145044C, 2120000070, 20884521056319; 8888145045C, 1924600106, 10884521056329; 8888145045C, 1926100279, 10884521056329; 8888145045C, 1926800382, 10884521056329; 8888145045C, 1926800383, 10884521056329; 8888145045C, 2017500126, 10884521056329; 8888145045C, 2026000089, 10884521056329; 8888145045C, 1924600106, 20884521056326; 8888145045C, 1926100279, 20884521056326; 8888145045C, 1926800382, 20884521056326; 8888145045C, 1926800383, 20884521056326; 8888145045C, 2017500126, 20884521056326; 8888145045C, 2026000089, 20884521056326; 8888145045C, 2100500127, 20884521056326; 8888145046C, 2026000091, 10884521056336; 8888145046C, 2026000091, 20884521056333

Distribution pattern

Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, DC, GU, & PR. The countries of Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belgium, Botswana, Brazil, Brunei Darussalam, Bulgaria, Cambodia, Canada, Canary Islands, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Faroe Islands, Finland, France, French Guiana, French Polynesia, Georgia, Germany, Ghana, Greece, Guatemala, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Islamic Republic of Iran, Ireland, Israel, Italy, Jamaica, Japan, Kenya, Republic of Korea, Kosovo, Kuwait, Lebanon, Luxembourg, Macao, Malaysia, Maldives, Malta, Mayotte, Mexico, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nicaragua, North Macedonia, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, San Marino, Saudi Arabia, Senegal, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Thailand, Trinidad And Tobago, Tunisia, Turkey, United Arab Emirates, United Kingdom, United States, Viet Nam, Virgin Islands, and Zimbabwe.

device · product 7 of 9

Palindrome SI Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusion.

Z-1318-2022
Recall number
Z-1318-2022
Initiated
June 08, 2022
Classification
Class I
Status
Ongoing
Recalling firm
Covidien Llc
Quantity
2,462 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-lumen void in the hub component, which may result in unanticipated fluid return during use.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-lumen void in the hub component, which may result in unanticipated fluid return during use.

Code information

Code Information organized as "Model No., Serial No., GTIN": 8888119368, 1925200090, 20884521012841; 8888119368, 1933700094, 20884521012841; 8888119368, 2001400077, 20884521012841; 8888119368, 2026000056, 20884521012841; 8888123408, 2009400114, 20884521012957; 8888128458, 1935100068, 20884521013039; 8888133508, 2026000060, 20884521013107; 8888145062, 2031800153, 10884521013407; 8888145062, 1933700095, 20884521013404; 8888145062, 2009400116, 20884521013404; 8888145062, 2031800131, 20884521013404; 8888145062, 2031800153, 20884521013404; 8888145063, 2000700056, 20884521013428; 8888145063, 2009400113, 20884521013428; 8888145063, 2027200181, 20884521013428; 8888145064, 2030100077, 20884521013442; 8888145065, 2026000067, 20884521013466; 8888145066, 2011900104, 10884521013476; 8888145066, 2019500162, 10884521013476; 8888145066, 2011900104, 20884521013473; 8888145066, 2019500162, 20884521013473

Distribution pattern

Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, DC, GU, & PR. The countries of Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belgium, Botswana, Brazil, Brunei Darussalam, Bulgaria, Cambodia, Canada, Canary Islands, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Faroe Islands, Finland, France, French Guiana, French Polynesia, Georgia, Germany, Ghana, Greece, Guatemala, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Islamic Republic of Iran, Ireland, Israel, Italy, Jamaica, Japan, Kenya, Republic of Korea, Kosovo, Kuwait, Lebanon, Luxembourg, Macao, Malaysia, Maldives, Malta, Mayotte, Mexico, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nicaragua, North Macedonia, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, San Marino, Saudi Arabia, Senegal, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Thailand, Trinidad And Tobago, Tunisia, Turkey, United Arab Emirates, United Kingdom, United States, Viet Nam, Virgin Islands, and Zimbabwe.

device · product 8 of 9

Palindrome HSI Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusion.

Z-1319-2022
Recall number
Z-1319-2022
Initiated
June 08, 2022
Classification
Class I
Status
Ongoing
Recalling firm
Covidien Llc
Quantity
13,526 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-lumen void in the hub component, which may result in unanticipated fluid return during use.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-lumen void in the hub component, which may result in unanticipated fluid return during use.

Code information

Code Information organized as "Model No., Serial No., GTIN": 8888119369, 2009300138, 10884521012875; 8888119369, 1935100070, 20884521012872; 8888119369, 2009300138, 20884521012872; 8888119369, 2026000146, 20884521012872; 8888119369, 2028200160, 20884521012872; 8888123409, 2000700062, 10884521012967; 8888123409, 2000700062, 20884521012964; 8888123409, 2001400081, 20884521012964; 8888123409, 2009400112, 20884521012964; 8888128459, 2127200434, 10884521013049; 8888128459, 2127200434, 20884521013046; 8888133509, 2026000147, 20884521013114; 8888145048, 2005600027, 10884521013278; 8888145048, 2009400106, 10884521013278; 8888145048, 2012100182, 10884521013278; 8888145048, 2012100188, 10884521013278; 8888145048, 2014900141, 10884521013278; 8888145048, 2028200161, 10884521013278; 8888145048, 2028200170, 10884521013278; 8888145048, 2031800114, 10884521013278; 8888145048, 2104900105, 10884521013278; 8888145048, 2110900138, 10884521013278; 8888145048, 2110900139, 10884521013278; 8888145048, 2005600027, 20884521013275; 8888145048, 2009400106, 20884521013275; 8888145048, 2012100182, 20884521013275; 8888145048, 2012100188, 20884521013275; 8888145048, 2028200161, 20884521013275; 8888145048, 2028200170, 20884521013275; 8888145048, 2031800114, 20884521013275; 8888145048, 2104900105, 20884521013275; 8888145048, 2110900138, 20884521013275; 8888145048, 2110900139, 20884521013275; 8888145049, 1915800111, 10884521017818; 8888145049, 2001400080, 10884521017818; 8888145049, 2012100183, 10884521017818; 8888145049, 2012100189, 10884521017818; 8888145049, 2014900142, 10884521017818; 8888145049, 2116200121, 10884521017818; 8888145049, 1915800111, 20884521017815; 8888145049, 2001400080, 20884521017815; 8888145049, 2012100183, 20884521017815; 8888145049, 2012100189, 20884521017815; 8888145049, 2014900142, 20884521017815; 8888145049, 2116200121, 20884521017815; 8888145050, 1915800081, 10884521013292; 8888145050, 2009300126, 10884521013292; 8888145050, 1915800081, 20884521013299; 8888145050, 1935100071, 20884521013299; 8888145050, 2009300088, 20884521013299; 8888145050, 2009300126, 20884521013299; 8888145057, 1933000053, 10884521013315; 8888145057, 1933000054, 10884521013315; 8888145057, 2002100110, 10884521013315; 8888145057, 2005600029, 10884521013315; 8888145057, 2005600030, 10884521013315; 8888145057, 2005600031, 10884521013315; 8888145057, 2009200095, 10884521013315; 8888145057, 2012100185, 10884521013315; 8888145057, 2014900140, 10884521013315; 8888145057, 2014900144, 10884521013315; 8888145057, 2028200158, 10884521013315; 8888145057, 2028200182, 10884521013315; 8888145057, 2031800115, 10884521013315; 8888145057, 2106900154, 10884521013315; 8888145057, 2124500110, 10884521013315; 8888145057, 1933000053, 20884521013312; 8888145057, 1933000054, 20884521013312; 8888145057, 1933700090, 20884521013312; 8888145057, 2002100110, 20884521013312; 8888145057, 2002900095, 20884521013312; 8888145057, 2005600029, 20884521013312; 8888145057, 2005600030, 20884521013312; 8888145057, 2005600031, 20884521013312; 8888145057, 2009200095, 20884521013312; 8888145057, 2009200096, 20884521013312; 8888145057, 2012100185, 20884521013312; 8888145057, 2014900140, 20884521013312; 8888145057, 2014900144, 20884521013312; 8888145057, 2028200158, 20884521013312; 8888145057, 2028200182, 20884521013312; 8888145057, 2031800115, 20884521013312; 8888145057, 2106900154, 20884521013312; 8888145057, 2124500110, 20884521013312; 8888145048C, 1924600107, 20884521083049; 8888145048C, 1927300067, 20884521083049; 8888145048C, 2026000155, 20884521083049; 8888145049C, 2018100027, 20884521083056; 8888145050C, 1926100281, 10884521083066; 8888145050C, 1926100281, 20884521083063; 8888145057C, 1927500052, 10884521083073; 8888145057C, 1927500052, 20884521083070; 8888145057C, 2026000161, 20884521083070

Distribution pattern

Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, DC, GU, & PR. The countries of Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belgium, Botswana, Brazil, Brunei Darussalam, Bulgaria, Cambodia, Canada, Canary Islands, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Faroe Islands, Finland, France, French Guiana, French Polynesia, Georgia, Germany, Ghana, Greece, Guatemala, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Islamic Republic of Iran, Ireland, Israel, Italy, Jamaica, Japan, Kenya, Republic of Korea, Kosovo, Kuwait, Lebanon, Luxembourg, Macao, Malaysia, Maldives, Malta, Mayotte, Mexico, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nicaragua, North Macedonia, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, San Marino, Saudi Arabia, Senegal, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Thailand, Trinidad And Tobago, Tunisia, Turkey, United Arab Emirates, United Kingdom, United States, Viet Nam, Virgin Islands, and Zimbabwe.

device · product 9 of 9

Mahurkar Chronic Carbothane (Maxid) Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusion.

Z-1320-2022
Recall number
Z-1320-2022
Initiated
June 08, 2022
Classification
Class I
Status
Ongoing
Recalling firm
Covidien Llc
Quantity
132,443 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-lumen void in the hub component, which may result in unanticipated fluid return during use.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-lumen void in the hub component, which may result in unanticipated fluid return during use.

Code information

Code Information organized as "Model No., Serial No., GTIN": 8888119362, 1928800230, 10884521056879; 8888119362, 1825400094, 20884521056876; 8888119362, 1912600107, 20884521056876; 8888119362, 1917600139, 20884521056876; 8888119362, 1917700080, 20884521056876; 8888119362, 1925200098, 20884521056876; 8888119362, 1927300146, 20884521056876; 8888119362, 1928800230, 20884521056876; 8888119362, 2023300144, 20884521056876; 8888119362, 2028200216, 20884521056876; 8888119362, 2122900239, 20884521056876; 8888119385, 1720700105, 20884521012421; 8888119385, 1724900109, 20884521012421; 8888119385, 2113300429, 20884521012421; 8888123402, 1927500121, 10884521056886; 8888123402, 2028200203, 10884521056886; 8888123402, 2110900059, 10884521056886; 8888123402, 1921700145, 20884521056883; 8888123402, 1924000138, 20884521056883; 8888123402, 1925200091, 20884521056883; 8888123402, 1927500120, 20884521056883; 8888123402, 1927500121, 20884521056883; 8888123402, 2023300143, 20884521056883; 8888123402, 2026000055, 20884521056883; 8888123402, 2028200203, 20884521056883; 8888123402, 2034400155, 20884521056883; 8888123402, 2104100105, 20884521056883; 8888123402, 2110900059, 20884521056883; 8888123402, 2113300432, 20884521056883; 8888123402, 2122900252, 20884521056883; 8888123435, 2034400156, 10884521012516; 8888123435, 1716500170, 20884521012513; 8888123435, 1716700115, 20884521012513; 8888123435, 1825400095, 20884521012513; 8888123435, 1831000101, 20884521012513; 8888123435, 2003700038, 20884521012513; 8888123435, 2034400156, 20884521012513; 8888123435, 2106900231, 20884521012513; 8888123435, 2113300430, 20884521012513; 8888128452, 2023300145, 10884521056916; 8888128452, 1716500171, 20884521056913; 8888128452, 1831000102, 20884521056913; 8888128452, 1904200079, 20884521056913; 8888128452, 2023300145, 20884521056913; 8888128485, 1716500172, 20884521012544; 8888128485, 1718600097, 20884521012544; 8888128485, 1720000119, 20884521012544; 8888133502, 1715100148, 20884521056920; 8888133535, 1924000139, 20884521013947; 8888145001, 1715800112, 10884521014084; 8888145001, 1722300112, 10884521014084; 8888145001, 1722600094, 10884521014084; 8888145001, 1723400093, 10884521014084; 8888145001, 1831000103, 10884521014084; 8888145001, 1904900119, 10884521014084; 8888145001, 1910200086, 10884521014084; 8888145001, 1912600085, 10884521014084; 8888145001, 1919700113, 10884521014084; 8888145001, 1925200099, 10884521014084; 8888145001, 2003700040, 10884521014084; 8888145001, 2008400137, 10884521014084; 8888145001, 2014900153, 10884521014084; 8888145001, 2014900166, 10884521014084; 8888145001, 2017500086, 10884521014084; 8888145001, 2017600091, 10884521014084; 8888145001, 2017600092, 10884521014084; 8888145001, 2017800060, 10884521014084; 8888145001, 1715300102, 20884521014081; 8888145001, 1715800112, 20884521014081; 8888145001, 1717200147, 20884521014081; 8888145001, 1717900143, 20884521014081; 8888145001, 1719300092, 20884521014081; 8888145001, 1720700107, 20884521014081; 8888145001, 1721300152, 20884521014081; 8888145001, 1722100148, 20884521014081; 8888145001, 1722300110, 20884521014081; 8888145001, 1722300111, 20884521014081; 8888145001, 1722300112, 20884521014081; 8888145001, 1722600094, 20884521014081; 8888145001, 1723400093, 20884521014081; 8888145001, 1723400094, 20884521014081; 8888145001, 1729100101, 20884521014081; 8888145001, 1810000171, 20884521014081; 8888145001, 1811500160, 20884521014081; 8888145001, 1827600114, 20884521014081; 8888145001, 1828200109, 20884521014081; 8888145001, 1829500106, 20884521014081; 8888145001, 1831000103, 20884521014081; 8888145001, 1834500194, 20884521014081; 8888145001, 1904200086, 20884521014081; 8888145001, 1904900119, 20884521014081; 8888145001, 1904900120, 20884521014081; 8888145001, 1905600120, 20884521014081; 8888145001, 1905600121, 20884521014081; 8888145001, 1906000118, 20884521014081; 8888145001, 1906000119, 20884521014081; 8888145001, 1910200086, 20884521014081; 8888145001, 1910200087, 20884521014081; 8888145001, 1910600255, 20884521014081; 8888145001, 1910600258, 20884521014081; 8888145001, 1912600085, 20884521014081; 8888145001, 1912600086, 20884521014081; 8888145001, 1919700113, 20884521014081; 8888145001, 1924000150, 20884521014081; 8888145001, 1925200099, 20884521014081; 8888145001, 2003700040, 20884521014081; 8888145001, 2008400137, 20884521014081; 8888145001, 2014900153, 20884521014081; 8888145001, 2014900164, 20884521014081; 8888145001, 2014900166, 20884521014081; 8888145001, 2014900167, 20884521014081; 8888145001, 2014900168, 20884521014081; 8888145001, 2014900169, 20884521014081; 8888145001, 2015300068, 20884521014081; 8888145001, 2017500086, 20884521014081; 8888145001, 2017600091, 20884521014081; 8888145001, 2017600092, 20884521014081; 8888145001, 2017800060, 20884521014081; 8888145001, 2124600201, 20884521014081; 8888145002, 1833100106, 10884521014145; 8888145002, 1914800162, 10884521014145; 8888145002, 1914800164, 10884521014145; 8888145002, 1920700130, 10884521014145; 8888145002, 2009300119, 10884521014145; 8888145002, 2027200195, 10884521014145; 8888145002, 2027200206, 10884521014145; 8888145002, 2034300098, 10884521014145; 8888145002, 1725100109, 20884521014142; 8888145002, 1728400115, 20884521014142; 8888145002, 1731200161, 20884521014142; 8888145002, 1732600137, 20884521014142; 8888145002, 1831600193, 20884521014142; 8888145002, 1833100106, 20884521014142; 8888145002, 1833800130, 20884521014142; 8888145002, 1906700180, 20884521014142; 8888145002, 1914400129, 20884521014142; 8888145002, 1914800162, 20884521014142; 8888145002, 1914800164, 20884521014142; 8888145002, 1917600065, 20884521014142; 8888145002, 1920700130, 20884521014142; 8888145002, 2009300119, 20884521014142; 8888145002, 2027200195, 20884521014142; 8888145002, 2027200206, 20884521014142; 8888145002, 2034300098, 20884521014142; 8888145003, 1727700140, 20884521014180; 8888145003, 1828900129, 20884521014180; 8888145003, 2001400108, 20884521014180; 8888145004, 1715100150, 20884521014203; 8888145004, 1725500097, 20884521014203; 8888145004, 1801000133, 20884521014203; 8888145027, 1720700106, 10884521056930; 8888145027, 1726300133, 10884521056930; 8888145027, 1805200080, 10884521056930; 8888145027, 1814300195, 10884521056930; 8888145027, 1822000073, 10884521056930; 8888145027, 1830300164, 10884521056930; 8888145027, 1926100268, 10884521056930; 8888145027, 1830300164, 20884521056937; 8888145027, 1916500080, 20884521056937; 8888145027, 1926100268, 20884521056937; 8888145027, 2003700043, 20884521056937; 8888145027, 2009300081, 20884521056937; 8888145027, 2026000074, 20884521056937; 8888145027, 2027300039, 20884521056937; 8888145027, 2034400151, 20884521056937; 8888145027, 2102500099, 20884521056937; 8888145027, 2104600166, 20884521056937; 8888145028, 1728400117, 10884521056947; 8888145028, 1805200081, 10884521056947; 8888145028, 1834500198, 10884521056947; 8888145028, 2034400152, 10884521056947; 8888145028, 2102500100, 10884521056947; 8888145028, 1834500198, 20884521056944; 8888145028, 1917600137, 20884521056944; 8888145028, 2002100143, 20884521056944; 8888145028, 2023300108, 20884521056944; 8888145028, 2031800136, 20884521056944; 8888145028, 2034400152, 20884521056944; 8888145028, 2102500100, 20884521056944; 8888145028, 2124600209, 20884521056944; 8888145029, 2031800133, 20884521056951; 8888145029, 2034400153, 20884521056951; 8888145030, 1729700114, 20884521056968; 8888145251, 1715100151, 10884521014220; 8888145251, 1715800113, 10884521014220; 8888145251, 1716500173, 10884521014220; 8888145251, 1717500004, 10884521014220; 8888145251, 1717900144, 10884521014220; 8888145251, 1718600098, 10884521014220; 8888145251, 1719300093, 10884521014220; 8888145251, 1720000120, 10884521014220; 8888145251, 1720700108, 10884521014220; 8888145251, 1721300153, 10884521014220; 8888145251, 1723400095, 10884521014220; 8888145251, 1727100080, 10884521014220; 8888145251, 1727700141, 10884521014220; 8888145251, 1731900229, 10884521014220; 8888145251, 1732600131, 10884521014220; 8888145251, 1733300154, 10884521014220; 8888145251, 1733700133, 10884521014220; 8888145251, 1733700188, 10884521014220; 8888145251, 1734700109, 10884521014220; 8888145251, 1800300132, 10884521014220; 8888145251, 1800300140, 10884521014220; 8888145251, 1805200106, 10884521014220; 8888145251, 1806600084, 10884521014220; 8888145251, 1808600071, 10884521014220; 8888145251, 1812900138, 10884521014220; 8888145251, 1812900139, 10884521014220; 8888145251, 1814600080, 10884521014220; 8888145251, 1827600117, 10884521014220; 8888145251, 1827600118, 10884521014220; 8888145251, 1831600195, 10884521014220; 8888145251, 1831600196, 10884521014220; 8888145251, 1833800140, 10884521014220; 8888145251, 1834500196, 10884521014220; 8888145251, 1834500206, 10884521014220; 8888145251, 1835100102, 10884521014220; 8888145251, 1835300203, 10884521014220; 8888145251, 1913000094, 10884521014220; 8888145251, 1914000293, 10884521014220; 8888145251, 1914000294, 10884521014220; 8888145251, 1914400122, 10884521014220; 8888145251, 1916500098, 10884521014220; 8888145251, 1916500099, 10884521014220; 8888145251, 1916500100, 10884521014220; 8888145251, 1926100264, 10884521014220; 8888145251, 1926100265, 10884521014220; 8888145251, 1926100266, 10884521014220; 8888145251, 1934400191, 10884521014220; 8888145251, 1934400192, 10884521014220; 8888145251, 2002100144, 10884521014220; 8888145251, 2014900172, 10884521014220; 8888145251, 2017500089, 10884521014220; 8888145251, 2017500132, 10884521014220; 8888145251, 2017500137, 10884521014220; 8888145251, 2019500267, 10884521014220; 8888145251, 2021000067, 10884521014220; 8888145251, 2021000068, 10884521014220; 8888145251, 2023300104, 10884521014220; 8888145251, 2034400176, 10884521014220; 8888145251, 2106900163, 10884521014220; 8888145251, 2106900204, 10884521014220; 8888145251, 2113300431, 10884521014220; 8888145251, 1715100151, 20884521014227; 8888145251, 1715800113, 20884521014227; 8888145251, 1716500173, 20884521014227; 8888145251, 1717500004, 20884521014227; 8888145251, 1717900144, 20884521014227; 8888145251, 1718600098, 20884521014227; 8888145251, 1719300093, 20884521014227; 8888145251, 1720000120, 20884521014227; 8888145251, 1720700108, 20884521014227; 8888145251, 1721300153, 20884521014227; 8888145251, 1723400095, 20884521014227; 8888145251, 1727100080, 20884521014227; 8888145251, 1727700141, 20884521014227; 8888145251, 1731900229, 20884521014227; 8888145251, 1732600131, 20884521014227; 8888145251, 1733300154, 20884521014227; 8888145251, 1733700133, 20884521014227; 8888145251, 1733700188, 20884521014227; 8888145251, 1734700109, 20884521014227; 8888145251, 1800300132, 20884521014227; 8888145251, 1800300140, 20884521014227; 8888145251, 1805200106, 20884521014227; 8888145251, 1806600084, 20884521014227; 8888145251, 1808600071, 20884521014227; 8888145251, 1812900138, 20884521014227; 8888145251, 1812900139, 20884521014227; 8888145251, 1814600080, 20884521014227; 8888145251, 1827600117, 20884521014227; 8888145251, 1827600118, 20884521014227; 8888145251, 1831600195, 20884521014227; 8888145251, 1831600196, 20884521014227; 8888145251, 1834500206, 20884521014227; 8888145251, 1835100102, 20884521014227; 8888145251, 1835300203, 20884521014227; 8888145251, 1913000094, 20884521014227; 8888145251, 1914000293, 20884521014227; 8888145251, 1914000294, 20884521014227; 8888145251, 1914400122, 20884521014227; 8888145251, 1914400123, 20884521014227; 8888145251, 1916500098, 20884521014227; 8888145251, 1916500099, 20884521014227; 8888145251, 1916500100, 20884521014227; 8888145251, 1926100264, 20884521014227; 8888145251, 1926100265, 20884521014227; 8888145251, 1926100266, 20884521014227; 8888145251, 1934400191, 20884521014227; 8888145251, 1934400192, 20884521014227; 8888145251, 2002100144, 20884521014227; 8888145251, 2008400141, 20884521014227; 8888145251, 2014900158, 20884521014227; 8888145251, 2014900172, 20884521014227; 8888145251, 2017500089, 20884521014227; 8888145251, 2017500132, 20884521014227; 8888145251, 2017500137, 20884521014227; 8888145251, 2019500267, 20884521014227; 8888145251, 2021000067, 20884521014227; 8888145251, 2021000068, 20884521014227; 8888145251, 2023300104, 20884521014227; 8888145251, 2034400174, 20884521014227; 8888145251, 2034400175, 20884521014227; 8888145251, 2034400176, 20884521014227; 8888145251, 2106900163, 20884521014227; 8888145251, 2106900204, 20884521014227; 8888145251, 2110900089, 20884521014227; 8888145251, 2113300431, 20884521014227; 8888145251, 2124600198, 20884521014227; 8888145251, 2201800126, 20884521014227; 8888145252, 1715100152, 10884521014244; 8888145252, 1717900145, 10884521014244; 8888145252, 1719300094, 10884521014244; 8888145252, 1720000121, 10884521014244; 8888145252, 1720700109, 10884521014244; 8888145252, 1721300168, 10884521014244; 8888145252, 1724300117, 10884521014244; 8888145252, 1727700139, 10884521014244; 8888145252, 1728400118, 10884521014244; 8888145252, 1729700117, 10884521014244; 8888145252, 1732700130, 10884521014244; 8888145252, 1801700129, 10884521014244; 8888145252, 1803100113, 10884521014244; 8888145252, 1803800135, 10884521014244; 8888145252, 1805900114, 10884521014244; 8888145252, 1805900133, 10884521014244; 8888145252, 1806600083, 10884521014244; 8888145252, 1807300175, 10884521014244; 8888145252, 1808600069, 10884521014244; 8888145252, 1811500157, 10884521014244; 8888145252, 1813600094, 10884521014244; 8888145252, 1817100080, 10884521014244; 8888145252, 1826200145, 10884521014244; 8888145252, 1826200167, 10884521014244; 8888145252, 1826800153, 10884521014244; 8888145252, 1828200107, 10884521014244; 8888145252, 1828200108, 10884521014244; 8888145252, 1828900131, 10884521014244; 8888145252, 1828900139, 10884521014244; 8888145252, 1828900140, 10884521014244; 8888145252, 1829500126, 10884521014244; 8888145252, 1830300140, 10884521014244; 8888145252, 1832300104, 10884521014244; 8888145252, 1832300105, 10884521014244; 8888145252, 1833100107, 10884521014244; 8888145252, 1833800142, 10884521014244; 8888145252, 1907800084, 10884521014244; 8888145252, 1907800085, 10884521014244; 8888145252, 1908400301, 10884521014244; 8888145252, 1913000179, 10884521014244; 8888145252, 1913000180, 10884521014244; 8888145252, 1913000181, 10884521014244; 8888145252, 1914000241, 10884521014244; 8888145252, 1914800206, 10884521014244; 8888145252, 1915800101, 10884521014244; 8888145252, 1917200226, 10884521014244; 8888145252, 1935100108, 10884521014244; 8888145252, 1935100109, 10884521014244; 8888145252, 2002900149, 10884521014244; 8888145252, 2009300077, 10884521014244; 8888145252, 2014900160, 10884521014244; 8888145252, 2015400078, 10884521014244; 8888145252, 2019500178, 10884521014244; 8888145252, 2019500270, 10884521014244; 8888145252, 2020400103, 10884521014244; 8888145252, 2020400104, 10884521014244; 8888145252, 2023300107, 10884521014244; 8888145252, 2027200208, 10884521014244; 8888145252, 2028000088, 10884521014244; 8888145252, 2030300103, 10884521014244; 8888145252, 2034400173, 10884521014244; 8888145252, 2104600208, 10884521014244; 8888145252, 2104600211, 10884521014244; 8888145252, 2104800077, 10884521014244; 8888145252, 2106900104, 10884521014244; 8888145252, 1717900145, 20884521014241; 8888145252, 1719300094, 20884521014241; 8888145252, 1720000121, 20884521014241; 8888145252, 1720700109, 20884521014241; 8888145252, 1721300168, 20884521014241; 8888145252, 1724300117, 20884521014241; 8888145252, 1727700139, 20884521014241; 8888145252, 1728400118, 20884521014241; 8888145252, 1800400103, 20884521014241; 8888145252, 1801700129, 20884521014241; 8888145252, 1805900114, 20884521014241; 8888145252, 1805900133, 20884521014241; 8888145252, 1806600083, 20884521014241; 8888145252, 1807300175, 20884521014241; 8888145252, 1808600069, 20884521014241; 8888145252, 1811500157, 20884521014241; 8888145252, 1813600094, 20884521014241; 8888145252, 1817100080, 20884521014241; 8888145252, 1826200167, 20884521014241; 8888145252, 1826800153, 20884521014241; 8888145252, 1828200107, 20884521014241; 8888145252, 1828200108, 20884521014241; 8888145252, 1828900140, 20884521014241; 8888145252, 1829500126, 20884521014241; 8888145252, 1830300140, 20884521014241; 8888145252, 1832300104, 20884521014241; 8888145252, 1832300105, 20884521014241; 8888145252, 1833100107, 20884521014241; 8888145252, 1833800142, 20884521014241; 8888145252, 1907800085, 20884521014241; 8888145252, 1908400301, 20884521014241; 8888145252, 1913000179, 20884521014241; 8888145252, 1913000180, 20884521014241; 8888145252, 1913000181, 20884521014241; 8888145252, 1914000241, 20884521014241; 8888145252, 1914800206, 20884521014241; 8888145252, 1915800101, 20884521014241; 8888145252, 1917200226, 20884521014241; 8888145252, 1935100108, 20884521014241; 8888145252, 1935100109, 20884521014241; 8888145252, 2002900149, 20884521014241; 8888145252, 2009300077, 20884521014241; 8888145252, 2014900160, 20884521014241; 8888145252, 2015400078, 20884521014241; 8888145252, 2019500174, 20884521014241; 8888145252, 2019500178, 20884521014241; 8888145252, 2019500270, 20884521014241; 8888145252, 2020400103, 20884521014241; 8888145252, 2020400104, 20884521014241; 8888145252, 2023300107, 20884521014241; 8888145252, 2027200208, 20884521014241; 8888145252, 2028000088, 20884521014241; 8888145252, 2030300103, 20884521014241; 8888145252, 2034400154, 20884521014241; 8888145252, 2034400173, 20884521014241; 8888145252, 2104100103, 20884521014241; 8888145252, 2104600208, 20884521014241; 8888145252, 2104600211, 20884521014241; 8888145252, 2104800077, 20884521014241; 8888145252, 2106900104, 20884521014241; 8888145252, 2124600211, 20884521014241; 8888145253, 1715800114, 10884521014275; 8888145253, 1716500174, 10884521014275; 8888145253, 1717200148, 10884521014275; 8888145253, 1717900197, 10884521014275; 8888145253, 1718600099, 10884521014275; 8888145253, 1719300095, 10884521014275; 8888145253, 1720000122, 10884521014275; 8888145253, 1721300154, 10884521014275; 8888145253, 1817700211, 10884521014275; 8888145253, 1828900082, 10884521014275; 8888145253, 1829500105, 10884521014275; 8888145253, 1829500127, 10884521014275; 8888145253, 1832300107, 10884521014275; 8888145253, 1833100105, 10884521014275; 8888145253, 1833800129, 10884521014275; 8888145253, 1917600122, 10884521014275; 8888145253, 1926100269, 10884521014275; 8888145253, 2026000061, 10884521014275; 8888145253, 2027200253, 10884521014275; 8888145253, 2102500101, 10884521014275; 8888145253, 2104100104, 10884521014275; 8888145253, 2124600200, 10884521014275; 8888145253, 1715800114, 20884521014272; 8888145253, 1716500174, 20884521014272; 8888145253, 1717200148, 20884521014272; 8888145253, 1717900197, 20884521014272; 8888145253, 1718600099, 20884521014272; 8888145253, 1719300095, 20884521014272; 8888145253, 1720000122, 20884521014272; 8888145253, 1721300154, 20884521014272; 8888145253, 1817700211, 20884521014272; 8888145253, 1829500127, 20884521014272; 8888145253, 1832300107, 20884521014272; 8888145253, 1833100105, 20884521014272; 8888145253, 1917600122, 20884521014272; 8888145253, 1926100269, 20884521014272; 8888145253, 2027200253, 20884521014272; 8888145253, 2102500101, 20884521014272; 8888145253, 2124600200, 20884521014272; 8888145254, 1715800115, 10884521014329; 8888145254, 1716500175, 10884521014329; 8888145254, 1717800131, 10884521014329; 8888145254, 1717900146, 10884521014329; 8888145254, 1718600100, 10884521014329; 8888145254, 1719300096, 10884521014329; 8888145254, 1720500101, 10884521014329; 8888145254, 1833100104, 10884521014329; 8888145254, 1835300224, 10884521014329; 8888145254, 1903500127, 10884521014329; 8888145254, 1917200227, 10884521014329; 8888145254, 2027200201, 10884521014329; 8888145254, 1715800115, 20884521014326; 8888145254, 1716500175, 20884521014326; 8888145254, 1717800131, 20884521014326; 8888145254, 1717900146, 20884521014326; 8888145254, 1718600100, 20884521014326; 8888145254, 1719300096, 20884521014326; 8888145254, 1720500101, 20884521014326; 8888145254, 1720700110, 20884521014326; 8888145254, 1833100104, 20884521014326; 8888145254, 1835300224, 20884521014326; 8888145254, 1903500127, 20884521014326

Distribution pattern

Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, DC, GU, & PR. The countries of Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belgium, Botswana, Brazil, Brunei Darussalam, Bulgaria, Cambodia, Canada, Canary Islands, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Faroe Islands, Finland, France, French Guiana, French Polynesia, Georgia, Germany, Ghana, Greece, Guatemala, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Islamic Republic of Iran, Ireland, Israel, Italy, Jamaica, Japan, Kenya, Republic of Korea, Kosovo, Kuwait, Lebanon, Luxembourg, Macao, Malaysia, Maldives, Malta, Mayotte, Mexico, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nicaragua, North Macedonia, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, San Marino, Saudi Arabia, Senegal, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Thailand, Trinidad And Tobago, Tunisia, Turkey, United Arab Emirates, United Kingdom, United States, Viet Nam, Virgin Islands, and Zimbabwe.