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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 70985

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

Open FDA event record

Event summary

Timeline bucket
April 23, 2015
Product types
Device
Classifications
Class II
Statuses
Terminated
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

62 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 62

Palindrome SI Chronic Catheter Kit 14.5 Fr x 19cm Item Code: 8888245062 The Palindrome SI Chronic Catheter is indicated for acute and chronic hemodialysis, apheresis, and infusion.

Z-1850-2015
Recall number
Z-1850-2015
Initiated
April 23, 2015
Classification
Class II
Status
Terminated
Recalling firm
Covidien LLC
Quantity
72,363 US - 24,631 Internationally

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
may not meet antimicrobial specification

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Catheters may not meet antimicrobial specification

Code information

Item codes identified with an expiry date of February 2018 and earlier

Distribution pattern

Worldwide Distribution - US (nationwide) and Internationally to Argentina, Austria, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Greece, Hong, Kong, India, Iran, Ireland, Israel, Italy, Libya, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, Norway, Oman, Panama, Philippines, Poland, Portugal, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey, Thailand, UAE, and United Kingdom.

device · product 2 of 62

Palindrome SI Chronic Catheter Kit 14.5 Fr x 23cm Item Code: 8888245063

Z-1851-2015
Recall number
Z-1851-2015
Initiated
April 23, 2015
Classification
Class II
Status
Terminated
Recalling firm
Covidien LLC
Quantity
72,363 US - 24,631 Internationally

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
may not meet antimicrobial specification

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Catheters may not meet antimicrobial specification

Code information

Item codes identified with an expiry date of February 2018 and earlier

Distribution pattern

Worldwide Distribution - US (nationwide) and Internationally to Argentina, Austria, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Greece, Hong, Kong, India, Iran, Ireland, Israel, Italy, Libya, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, Norway, Oman, Panama, Philippines, Poland, Portugal, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey, Thailand, UAE, and United Kingdom.

device · product 3 of 62

Palindrome SI Chronic Catheter Kit 14.5 Fr x 28cm Item Code: 8888245064

Z-1852-2015
Recall number
Z-1852-2015
Initiated
April 23, 2015
Classification
Class II
Status
Terminated
Recalling firm
Covidien LLC
Quantity
72,363 US - 24,631 Internationally

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
may not meet antimicrobial specification

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Catheters may not meet antimicrobial specification

Code information

Item codes identified with an expiry date of February 2018 and earlier

Distribution pattern

Worldwide Distribution - US (nationwide) and Internationally to Argentina, Austria, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Greece, Hong, Kong, India, Iran, Ireland, Israel, Italy, Libya, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, Norway, Oman, Panama, Philippines, Poland, Portugal, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey, Thailand, UAE, and United Kingdom.

device · product 4 of 62

Palindrome SI Chronic Catheter Kit 14.5 Fr x 28cm Item Code: 8888245064

Z-1853-2015
Recall number
Z-1853-2015
Initiated
April 23, 2015
Classification
Class II
Status
Terminated
Recalling firm
Covidien LLC
Quantity
72,363 US - 24,631 Internationally

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
may not meet antimicrobial specification

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Catheters may not meet antimicrobial specification

Code information

Item codes identified with an expiry date of February 2018 and earlier

Distribution pattern

Worldwide Distribution - US (nationwide) and Internationally to Argentina, Austria, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Greece, Hong, Kong, India, Iran, Ireland, Israel, Italy, Libya, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, Norway, Oman, Panama, Philippines, Poland, Portugal, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey, Thailand, UAE, and United Kingdom.

device · product 5 of 62

Palindrome SI Chronic Catheter Kit 14.5 Fr x 28cm Item Code: 8888245064

Z-1854-2015
Recall number
Z-1854-2015
Initiated
April 23, 2015
Classification
Class II
Status
Terminated
Recalling firm
Covidien LLC
Quantity
72,363 US - 24,631 Internationally

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
may not meet antimicrobial specification

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Catheters may not meet antimicrobial specification

Code information

Item codes identified with an expiry date of February 2018 and earlier

Distribution pattern

Worldwide Distribution - US (nationwide) and Internationally to Argentina, Austria, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Greece, Hong, Kong, India, Iran, Ireland, Israel, Italy, Libya, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, Norway, Oman, Panama, Philippines, Poland, Portugal, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey, Thailand, UAE, and United Kingdom.

device · product 6 of 62

Palindrome SI Chronic Catheter Sport Pack 14.5 Fr x 33 cm Item Code: 8888233508

Z-1857-2015
Recall number
Z-1857-2015
Initiated
April 23, 2015
Classification
Class II
Status
Terminated
Recalling firm
Covidien LLC
Quantity
72,363 US - 24,631 Internationally

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
may not meet antimicrobial specification

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Catheters may not meet antimicrobial specification

Code information

Item codes identified with an expiry date of February 2018 and earlier

Distribution pattern

Worldwide Distribution - US (nationwide) and Internationally to Argentina, Austria, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Greece, Hong, Kong, India, Iran, Ireland, Israel, Italy, Libya, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, Norway, Oman, Panama, Philippines, Poland, Portugal, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey, Thailand, UAE, and United Kingdom.

device · product 7 of 62

Palindrome SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 19cm Item Code: 8888145062

Z-1858-2015
Recall number
Z-1858-2015
Initiated
April 23, 2015
Classification
Class II
Status
Terminated
Recalling firm
Covidien LLC
Quantity
72,363 US - 24,631 Internationally

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
may not meet antimicrobial specification

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Catheters may not meet antimicrobial specification

Code information

Item codes identified with an expiry date of February 2018 and earlier

Distribution pattern

Worldwide Distribution - US (nationwide) and Internationally to Argentina, Austria, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Greece, Hong, Kong, India, Iran, Ireland, Israel, Italy, Libya, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, Norway, Oman, Panama, Philippines, Poland, Portugal, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey, Thailand, UAE, and United Kingdom.

device · product 8 of 62

Palindrome SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 19cm Item Code: 8888145062C

Z-1859-2015
Recall number
Z-1859-2015
Initiated
April 23, 2015
Classification
Class II
Status
Terminated
Recalling firm
Covidien LLC
Quantity
72,363 US - 24,631 Internationally

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
may not meet antimicrobial specification

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Catheters may not meet antimicrobial specification

Code information

Item codes identified with an expiry date of February 2018 and earlier

Distribution pattern

Worldwide Distribution - US (nationwide) and Internationally to Argentina, Austria, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Greece, Hong, Kong, India, Iran, Ireland, Israel, Italy, Libya, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, Norway, Oman, Panama, Philippines, Poland, Portugal, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey, Thailand, UAE, and United Kingdom.

device · product 9 of 62

Palindrome SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 23cm Item Code: 8888145063

Z-1860-2015
Recall number
Z-1860-2015
Initiated
April 23, 2015
Classification
Class II
Status
Terminated
Recalling firm
Covidien LLC
Quantity
72,363 US - 24,631 Internationally

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
may not meet antimicrobial specification

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Catheters may not meet antimicrobial specification

Code information

Item codes identified with an expiry date of February 2018 and earlier

Distribution pattern

Worldwide Distribution - US (nationwide) and Internationally to Argentina, Austria, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Greece, Hong, Kong, India, Iran, Ireland, Israel, Italy, Libya, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, Norway, Oman, Panama, Philippines, Poland, Portugal, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey, Thailand, UAE, and United Kingdom.

device · product 10 of 62

Palindrome SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 23cm Item Code: 8888145063C

Z-1861-2015
Recall number
Z-1861-2015
Initiated
April 23, 2015
Classification
Class II
Status
Terminated
Recalling firm
Covidien LLC
Quantity
72,363 US - 24,631 Internationally

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
may not meet antimicrobial specification

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Catheters may not meet antimicrobial specification

Code information

Item codes identified with an expiry date of February 2018 and earlier

Distribution pattern

Worldwide Distribution - US (nationwide) and Internationally to Argentina, Austria, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Greece, Hong, Kong, India, Iran, Ireland, Israel, Italy, Libya, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, Norway, Oman, Panama, Philippines, Poland, Portugal, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey, Thailand, UAE, and United Kingdom.

device · product 11 of 62

Palindrome SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28cm Item Code:8888145064

Z-1862-2015
Recall number
Z-1862-2015
Initiated
April 23, 2015
Classification
Class II
Status
Terminated
Recalling firm
Covidien LLC
Quantity
72,363 US - 24,631 Internationally

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
may not meet antimicrobial specification

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Catheters may not meet antimicrobial specification

Code information

Item codes identified with an expiry date of February 2018 and earlier

Distribution pattern

Worldwide Distribution - US (nationwide) and Internationally to Argentina, Austria, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Greece, Hong, Kong, India, Iran, Ireland, Israel, Italy, Libya, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, Norway, Oman, Panama, Philippines, Poland, Portugal, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey, Thailand, UAE, and United Kingdom.

device · product 12 of 62

Palindrome SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 8888145064C

Z-1863-2015
Recall number
Z-1863-2015
Initiated
April 23, 2015
Classification
Class II
Status
Terminated
Recalling firm
Covidien LLC
Quantity
72,363 US - 24,631 Internationally

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
may not meet antimicrobial specification

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Catheters may not meet antimicrobial specification

Code information

Item codes identified with an expiry date of February 2018 and earlier

Distribution pattern

Worldwide Distribution - US (nationwide) and Internationally to Argentina, Austria, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Greece, Hong, Kong, India, Iran, Ireland, Israel, Italy, Libya, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, Norway, Oman, Panama, Philippines, Poland, Portugal, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey, Thailand, UAE, and United Kingdom.

device · product 13 of 62

Palindrome SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 33cm Item Code: 8888145065

Z-1864-2015
Recall number
Z-1864-2015
Initiated
April 23, 2015
Classification
Class II
Status
Terminated
Recalling firm
Covidien LLC
Quantity
72,363 US - 24,631 Internationally

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
may not meet antimicrobial specification

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Catheters may not meet antimicrobial specification

Code information

Item codes identified with an expiry date of February 2018 and earlier

Distribution pattern

Worldwide Distribution - US (nationwide) and Internationally to Argentina, Austria, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Greece, Hong, Kong, India, Iran, Ireland, Israel, Italy, Libya, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, Norway, Oman, Panama, Philippines, Poland, Portugal, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey, Thailand, UAE, and United Kingdom.

device · product 14 of 62

Palindrome SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 33cm Item Code: 8888145065C

Z-1865-2015
Recall number
Z-1865-2015
Initiated
April 23, 2015
Classification
Class II
Status
Terminated
Recalling firm
Covidien LLC
Quantity
72,363 US - 24,631 Internationally

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
may not meet antimicrobial specification

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Catheters may not meet antimicrobial specification

Code information

Item codes identified with an expiry date of February 2018 and earlier

Distribution pattern

Worldwide Distribution - US (nationwide) and Internationally to Argentina, Austria, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Greece, Hong, Kong, India, Iran, Ireland, Israel, Italy, Libya, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, Norway, Oman, Panama, Philippines, Poland, Portugal, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey, Thailand, UAE, and United Kingdom.

device · product 15 of 62

Palindrome SI Chronic Catheter Kit 14.5 Fr x 55cm Item Code: 8888145066

Z-1866-2015
Recall number
Z-1866-2015
Initiated
April 23, 2015
Classification
Class II
Status
Terminated
Recalling firm
Covidien LLC
Quantity
72,363 US - 24,631 Internationally

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
may not meet antimicrobial specification

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Catheters may not meet antimicrobial specification

Code information

Item codes identified with an expiry date of February 2018 and earlier

Distribution pattern

Worldwide Distribution - US (nationwide) and Internationally to Argentina, Austria, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Greece, Hong, Kong, India, Iran, Ireland, Israel, Italy, Libya, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, Norway, Oman, Panama, Philippines, Poland, Portugal, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey, Thailand, UAE, and United Kingdom.

device · product 16 of 62

Palindrome SI Chronic Catheter Kit 14.5 Fr x 55cm Item Code: 8888145066C

Z-1867-2015
Recall number
Z-1867-2015
Initiated
April 23, 2015
Classification
Class II
Status
Terminated
Recalling firm
Covidien LLC
Quantity
72,363 US - 24,631 Internationally

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
may not meet antimicrobial specification

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Catheters may not meet antimicrobial specification

Code information

Item codes identified with an expiry date of February 2018 and earlier

Distribution pattern

Worldwide Distribution - US (nationwide) and Internationally to Argentina, Austria, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Greece, Hong, Kong, India, Iran, Ireland, Israel, Italy, Libya, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, Norway, Oman, Panama, Philippines, Poland, Portugal, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey, Thailand, UAE, and United Kingdom.

device · product 17 of 62

Palindrome Precision SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 19cm Item Code: 8888145062P

Z-1868-2015
Recall number
Z-1868-2015
Initiated
April 23, 2015
Classification
Class II
Status
Terminated
Recalling firm
Covidien LLC
Quantity
72,363 US - 24,631 Internationally

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
may not meet antimicrobial specification

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Catheters may not meet antimicrobial specification

Code information

Item codes identified with an expiry date of February 2018 and earlier

Distribution pattern

Worldwide Distribution - US (nationwide) and Internationally to Argentina, Austria, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Greece, Hong, Kong, India, Iran, Ireland, Israel, Italy, Libya, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, Norway, Oman, Panama, Philippines, Poland, Portugal, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey, Thailand, UAE, and United Kingdom.

device · product 18 of 62

Palindrome Precision SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 19cm Item Code: 8888145062CP

Z-1869-2015
Recall number
Z-1869-2015
Initiated
April 23, 2015
Classification
Class II
Status
Terminated
Recalling firm
Covidien LLC
Quantity
72,363 US - 24,631 Internationally

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
may not meet antimicrobial specification

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Catheters may not meet antimicrobial specification

Code information

Item codes identified with an expiry date of February 2018 and earlier

Distribution pattern

Worldwide Distribution - US (nationwide) and Internationally to Argentina, Austria, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Greece, Hong, Kong, India, Iran, Ireland, Israel, Italy, Libya, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, Norway, Oman, Panama, Philippines, Poland, Portugal, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey, Thailand, UAE, and United Kingdom.

device · product 19 of 62

Palindrome Precision SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 23cm Item Code: 8888145063P

Z-1870-2015
Recall number
Z-1870-2015
Initiated
April 23, 2015
Classification
Class II
Status
Terminated
Recalling firm
Covidien LLC
Quantity
72,363 US - 24,631 Internationally

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
may not meet antimicrobial specification

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Catheters may not meet antimicrobial specification

Code information

Item codes identified with an expiry date of February 2018 and earlier

Distribution pattern

Worldwide Distribution - US (nationwide) and Internationally to Argentina, Austria, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Greece, Hong, Kong, India, Iran, Ireland, Israel, Italy, Libya, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, Norway, Oman, Panama, Philippines, Poland, Portugal, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey, Thailand, UAE, and United Kingdom.

device · product 20 of 62

Palindrome Precision SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 23cm Item Code: 8888145063CP

Z-1871-2015
Recall number
Z-1871-2015
Initiated
April 23, 2015
Classification
Class II
Status
Terminated
Recalling firm
Covidien LLC
Quantity
72,363 US - 24,631 Internationally

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
may not meet antimicrobial specification

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Catheters may not meet antimicrobial specification

Code information

Item codes identified with an expiry date of February 2018 and earlier

Distribution pattern

Worldwide Distribution - US (nationwide) and Internationally to Argentina, Austria, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Greece, Hong, Kong, India, Iran, Ireland, Israel, Italy, Libya, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, Norway, Oman, Panama, Philippines, Poland, Portugal, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey, Thailand, UAE, and United Kingdom.

device · product 21 of 62

Palindrome Precision SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 8888145064P

Z-1872-2015
Recall number
Z-1872-2015
Initiated
April 23, 2015
Classification
Class II
Status
Terminated
Recalling firm
Covidien LLC
Quantity
72,363 US - 24,631 Internationally

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
may not meet antimicrobial specification

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Catheters may not meet antimicrobial specification

Code information

Item codes identified with an expiry date of February 2018 and earlier

Distribution pattern

Worldwide Distribution - US (nationwide) and Internationally to Argentina, Austria, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Greece, Hong, Kong, India, Iran, Ireland, Israel, Italy, Libya, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, Norway, Oman, Panama, Philippines, Poland, Portugal, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey, Thailand, UAE, and United Kingdom.

device · product 22 of 62

Palindrome Precision SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 8888145064CP

Z-1873-2015
Recall number
Z-1873-2015
Initiated
April 23, 2015
Classification
Class II
Status
Terminated
Recalling firm
Covidien LLC
Quantity
72,363 US - 24,631 Internationally

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
may not meet antimicrobial specification

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Catheters may not meet antimicrobial specification

Code information

Item codes identified with an expiry date of February 2018 and earlier

Distribution pattern

Worldwide Distribution - US (nationwide) and Internationally to Argentina, Austria, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Greece, Hong, Kong, India, Iran, Ireland, Israel, Italy, Libya, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, Norway, Oman, Panama, Philippines, Poland, Portugal, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey, Thailand, UAE, and United Kingdom.

device · product 23 of 62

Palindrome Precision SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 33cm Item Code: 8888145065P

Z-1874-2015
Recall number
Z-1874-2015
Initiated
April 23, 2015
Classification
Class II
Status
Terminated
Recalling firm
Covidien LLC
Quantity
72,363 US - 24,631 Internationally

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
may not meet antimicrobial specification

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Catheters may not meet antimicrobial specification

Code information

Item codes identified with an expiry date of February 2018 and earlier

Distribution pattern

Worldwide Distribution - US (nationwide) and Internationally to Argentina, Austria, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Greece, Hong, Kong, India, Iran, Ireland, Israel, Italy, Libya, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, Norway, Oman, Panama, Philippines, Poland, Portugal, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey, Thailand, UAE, and United Kingdom.

device · product 24 of 62

Palindrome Precision SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 33cmItem Code: 8888145065CP

Z-1875-2015
Recall number
Z-1875-2015
Initiated
April 23, 2015
Classification
Class II
Status
Terminated
Recalling firm
Covidien LLC
Quantity
72,363 US - 24,631 Internationally

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
may not meet antimicrobial specification

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Catheters may not meet antimicrobial specification

Code information

Item codes identified with an expiry date of February 2018 and earlier

Distribution pattern

Worldwide Distribution - US (nationwide) and Internationally to Argentina, Austria, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Greece, Hong, Kong, India, Iran, Ireland, Israel, Italy, Libya, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, Norway, Oman, Panama, Philippines, Poland, Portugal, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey, Thailand, UAE, and United Kingdom.

device · product 25 of 62

Palindrome Precision SI Chronic Catheter Kit 14.5 Fr x 44cm Item Code: 8888146144P

Z-1876-2015
Recall number
Z-1876-2015
Initiated
April 23, 2015
Classification
Class II
Status
Terminated
Recalling firm
Covidien LLC
Quantity
72,363 US - 24,631 Internationally

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
may not meet antimicrobial specification

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Catheters may not meet antimicrobial specification

Code information

Item codes identified with an expiry date of February 2018 and earlier

Distribution pattern

Worldwide Distribution - US (nationwide) and Internationally to Argentina, Austria, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Greece, Hong, Kong, India, Iran, Ireland, Israel, Italy, Libya, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, Norway, Oman, Panama, Philippines, Poland, Portugal, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey, Thailand, UAE, and United Kingdom.

device · product 26 of 62

Palindrome Precision SI Chronic Catheter Kit 14.5 Fr x 44cm Item Code: 8888146144CP

Z-1877-2015
Recall number
Z-1877-2015
Initiated
April 23, 2015
Classification
Class II
Status
Terminated
Recalling firm
Covidien LLC
Quantity
72,363 US - 24,631 Internationally

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
may not meet antimicrobial specification

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Catheters may not meet antimicrobial specification

Code information

Item codes identified with an expiry date of February 2018 and earlier

Distribution pattern

Worldwide Distribution - US (nationwide) and Internationally to Argentina, Austria, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Greece, Hong, Kong, India, Iran, Ireland, Israel, Italy, Libya, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, Norway, Oman, Panama, Philippines, Poland, Portugal, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey, Thailand, UAE, and United Kingdom.

device · product 27 of 62

Palindrome Precision SI Chronic Catheter Kit 14.5 Fr x 55cm Item Code: 8888145066P

Z-1878-2015
Recall number
Z-1878-2015
Initiated
April 23, 2015
Classification
Class II
Status
Terminated
Recalling firm
Covidien LLC
Quantity
72,363 US - 24,631 Internationally

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
may not meet antimicrobial specification

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Catheters may not meet antimicrobial specification

Code information

Item codes identified with an expiry date of February 2018 and earlier

Distribution pattern

Worldwide Distribution - US (nationwide) and Internationally to Argentina, Austria, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Greece, Hong, Kong, India, Iran, Ireland, Israel, Italy, Libya, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, Norway, Oman, Panama, Philippines, Poland, Portugal, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey, Thailand, UAE, and United Kingdom.

device · product 28 of 62

Palindrome Precision SI Chronic Catheter Kit 14.5 Fr x 55cm Item Code: 8888145066CP

Z-1879-2015
Recall number
Z-1879-2015
Initiated
April 23, 2015
Classification
Class II
Status
Terminated
Recalling firm
Covidien LLC
Quantity
72,363 US - 24,631 Internationally

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
may not meet antimicrobial specification

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Catheters may not meet antimicrobial specification

Code information

Item codes identified with an expiry date of February 2018 and earlier

Distribution pattern

Worldwide Distribution - US (nationwide) and Internationally to Argentina, Austria, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Greece, Hong, Kong, India, Iran, Ireland, Israel, Italy, Libya, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, Norway, Oman, Panama, Philippines, Poland, Portugal, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey, Thailand, UAE, and United Kingdom.

device · product 29 of 62

Palindrome Precision SI Chronic Catheter Kit 14.5 Fr x 55cm Item Code: 8888145066CP

Z-1880-2015
Recall number
Z-1880-2015
Initiated
April 23, 2015
Classification
Class II
Status
Terminated
Recalling firm
Covidien LLC
Quantity
72,363 US - 24,631 Internationally

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
may not meet antimicrobial specification

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Catheters may not meet antimicrobial specification

Code information

Item codes identified with an expiry date of February 2018 and earlier

Distribution pattern

Worldwide Distribution - US (nationwide) and Internationally to Argentina, Austria, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Greece, Hong, Kong, India, Iran, Ireland, Israel, Italy, Libya, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, Norway, Oman, Panama, Philippines, Poland, Portugal, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey, Thailand, UAE, and United Kingdom.

device · product 30 of 62

Palindrome SI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 23cm Item Code: 8888123408

Z-1881-2015
Recall number
Z-1881-2015
Initiated
April 23, 2015
Classification
Class II
Status
Terminated
Recalling firm
Covidien LLC
Quantity
72,363 US - 24,631 Internationally

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
may not meet antimicrobial specification

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Catheters may not meet antimicrobial specification

Code information

Item codes identified with an expiry date of February 2018 and earlier

Distribution pattern

Worldwide Distribution - US (nationwide) and Internationally to Argentina, Austria, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Greece, Hong, Kong, India, Iran, Ireland, Israel, Italy, Libya, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, Norway, Oman, Panama, Philippines, Poland, Portugal, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey, Thailand, UAE, and United Kingdom.

device · product 31 of 62

Palindrome SI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 8888128458

Z-1882-2015
Recall number
Z-1882-2015
Initiated
April 23, 2015
Classification
Class II
Status
Terminated
Recalling firm
Covidien LLC
Quantity
72,363 US - 24,631 Internationally

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
may not meet antimicrobial specification

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Catheters may not meet antimicrobial specification

Code information

Item codes identified with an expiry date of February 2018 and earlier

Distribution pattern

Worldwide Distribution - US (nationwide) and Internationally to Argentina, Austria, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Greece, Hong, Kong, India, Iran, Ireland, Israel, Italy, Libya, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, Norway, Oman, Panama, Philippines, Poland, Portugal, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey, Thailand, UAE, and United Kingdom.

device · product 32 of 62

Palindrome SI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 8888128458

Z-1883-2015
Recall number
Z-1883-2015
Initiated
April 23, 2015
Classification
Class II
Status
Terminated
Recalling firm
Covidien LLC
Quantity
72,363 US - 24,631 Internationally

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
may not meet antimicrobial specification

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Catheters may not meet antimicrobial specification

Code information

Item codes identified with an expiry date of February 2018 and earlier

Distribution pattern

Worldwide Distribution - US (nationwide) and Internationally to Argentina, Austria, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Greece, Hong, Kong, India, Iran, Ireland, Israel, Italy, Libya, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, Norway, Oman, Panama, Philippines, Poland, Portugal, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey, Thailand, UAE, and United Kingdom.

device · product 33 of 62

Palindrome Precision SI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 19cm Item Code: 8888119368P

Z-1884-2015
Recall number
Z-1884-2015
Initiated
April 23, 2015
Classification
Class II
Status
Terminated
Recalling firm
Covidien LLC
Quantity
72,363 US - 24,631 Internationally

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
may not meet antimicrobial specification

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Catheters may not meet antimicrobial specification

Code information

Item codes identified with an expiry date of February 2018 and earlier

Distribution pattern

Worldwide Distribution - US (nationwide) and Internationally to Argentina, Austria, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Greece, Hong, Kong, India, Iran, Ireland, Israel, Italy, Libya, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, Norway, Oman, Panama, Philippines, Poland, Portugal, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey, Thailand, UAE, and United Kingdom.

device · product 34 of 62

Palindrome Precision SI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 23cm Item Code: 8888123408P

Z-1885-2015
Recall number
Z-1885-2015
Initiated
April 23, 2015
Classification
Class II
Status
Terminated
Recalling firm
Covidien LLC
Quantity
72,363 US - 24,631 Internationally

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
may not meet antimicrobial specification

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Catheters may not meet antimicrobial specification

Code information

Item codes identified with an expiry date of February 2018 and earlier

Distribution pattern

Worldwide Distribution - US (nationwide) and Internationally to Argentina, Austria, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Greece, Hong, Kong, India, Iran, Ireland, Israel, Italy, Libya, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, Norway, Oman, Panama, Philippines, Poland, Portugal, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey, Thailand, UAE, and United Kingdom.

device · product 35 of 62

Palindrome Precision SI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 8888128458P

Z-1886-2015
Recall number
Z-1886-2015
Initiated
April 23, 2015
Classification
Class II
Status
Terminated
Recalling firm
Covidien LLC
Quantity
72,363 US - 24,631 Internationally

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
may not meet antimicrobial specification

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Catheters may not meet antimicrobial specification

Code information

Item codes identified with an expiry date of February 2018 and earlier

Distribution pattern

Worldwide Distribution - US (nationwide) and Internationally to Argentina, Austria, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Greece, Hong, Kong, India, Iran, Ireland, Israel, Italy, Libya, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, Norway, Oman, Panama, Philippines, Poland, Portugal, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey, Thailand, UAE, and United Kingdom.

device · product 36 of 62

Palindrome Precision SI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 33cm Item Code: 8888133508P

Z-1887-2015
Recall number
Z-1887-2015
Initiated
April 23, 2015
Classification
Class II
Status
Terminated
Recalling firm
Covidien LLC
Quantity
72,363 US - 24,631 Internationally

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
may not meet antimicrobial specification

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Catheters may not meet antimicrobial specification

Code information

Item codes identified with an expiry date of February 2018 and earlier

Distribution pattern

Worldwide Distribution - US (nationwide) and Internationally to Argentina, Austria, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Greece, Hong, Kong, India, Iran, Ireland, Israel, Italy, Libya, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, Norway, Oman, Panama, Philippines, Poland, Portugal, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey, Thailand, UAE, and United Kingdom.

device · product 37 of 62

Palindrome Precision SI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 33cm Item Code: 8888133508P

Z-1888-2015
Recall number
Z-1888-2015
Initiated
April 23, 2015
Classification
Class II
Status
Terminated
Recalling firm
Covidien LLC
Quantity
72,363 US - 24,631 Internationally

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
may not meet antimicrobial specification

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Catheters may not meet antimicrobial specification

Code information

Item codes identified with an expiry date of February 2018 and earlier

Distribution pattern

Worldwide Distribution - US (nationwide) and Internationally to Argentina, Austria, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Greece, Hong, Kong, India, Iran, Ireland, Israel, Italy, Libya, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, Norway, Oman, Panama, Philippines, Poland, Portugal, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey, Thailand, UAE, and United Kingdom.

device · product 38 of 62

Palindrome HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 19cm Item Code: 8888145057C

Z-1889-2015
Recall number
Z-1889-2015
Initiated
April 23, 2015
Classification
Class II
Status
Terminated
Recalling firm
Covidien LLC
Quantity
72,363 US - 24,631 Internationally

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
may not meet antimicrobial specification

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Catheters may not meet antimicrobial specification

Code information

Item codes identified with an expiry date of February 2018 and earlier

Distribution pattern

Worldwide Distribution - US (nationwide) and Internationally to Argentina, Austria, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Greece, Hong, Kong, India, Iran, Ireland, Israel, Italy, Libya, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, Norway, Oman, Panama, Philippines, Poland, Portugal, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey, Thailand, UAE, and United Kingdom.

device · product 39 of 62

Palindrome HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 19cm Item Code: 8888145048

Z-1890-2015
Recall number
Z-1890-2015
Initiated
April 23, 2015
Classification
Class II
Status
Terminated
Recalling firm
Covidien LLC
Quantity
72,363 US - 24,631 Internationally

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
may not meet antimicrobial specification

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Catheters may not meet antimicrobial specification

Code information

Item codes identified with an expiry date of February 2018 and earlier

Distribution pattern

Worldwide Distribution - US (nationwide) and Internationally to Argentina, Austria, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Greece, Hong, Kong, India, Iran, Ireland, Israel, Italy, Libya, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, Norway, Oman, Panama, Philippines, Poland, Portugal, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey, Thailand, UAE, and United Kingdom.

device · product 40 of 62

Palindrome HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 23cm Item Code: 8888145048C

Z-1891-2015
Recall number
Z-1891-2015
Initiated
April 23, 2015
Classification
Class II
Status
Terminated
Recalling firm
Covidien LLC
Quantity
72,363 US - 24,631 Internationally

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
may not meet antimicrobial specification

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Catheters may not meet antimicrobial specification

Code information

Item codes identified with an expiry date of February 2018 and earlier

Distribution pattern

Worldwide Distribution - US (nationwide) and Internationally to Argentina, Austria, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Greece, Hong, Kong, India, Iran, Ireland, Israel, Italy, Libya, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, Norway, Oman, Panama, Philippines, Poland, Portugal, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey, Thailand, UAE, and United Kingdom.

device · product 41 of 62

Palindrome HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 8888145049

Z-1892-2015
Recall number
Z-1892-2015
Initiated
April 23, 2015
Classification
Class II
Status
Terminated
Recalling firm
Covidien LLC
Quantity
72,363 US - 24,631 Internationally

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
may not meet antimicrobial specification

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Catheters may not meet antimicrobial specification

Code information

Item codes identified with an expiry date of February 2018 and earlier

Distribution pattern

Worldwide Distribution - US (nationwide) and Internationally to Argentina, Austria, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Greece, Hong, Kong, India, Iran, Ireland, Israel, Italy, Libya, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, Norway, Oman, Panama, Philippines, Poland, Portugal, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey, Thailand, UAE, and United Kingdom.

device · product 42 of 62

Palindrome HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28cm Item Code:8888145049C

Z-1893-2015
Recall number
Z-1893-2015
Initiated
April 23, 2015
Classification
Class II
Status
Terminated
Recalling firm
Covidien LLC
Quantity
72,363 US - 24,631 Internationally

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
may not meet antimicrobial specification

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Catheters may not meet antimicrobial specification

Code information

Item codes identified with an expiry date of February 2018 and earlier

Distribution pattern

Worldwide Distribution - US (nationwide) and Internationally to Argentina, Austria, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Greece, Hong, Kong, India, Iran, Ireland, Israel, Italy, Libya, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, Norway, Oman, Panama, Philippines, Poland, Portugal, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey, Thailand, UAE, and United Kingdom.

device · product 43 of 62

Palindrome HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 33cm Item Code: 8888145050

Z-1894-2015
Recall number
Z-1894-2015
Initiated
April 23, 2015
Classification
Class II
Status
Terminated
Recalling firm
Covidien LLC
Quantity
72,363 US - 24,631 Internationally

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
may not meet antimicrobial specification

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Catheters may not meet antimicrobial specification

Code information

Item codes identified with an expiry date of February 2018 and earlier

Distribution pattern

Worldwide Distribution - US (nationwide) and Internationally to Argentina, Austria, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Greece, Hong, Kong, India, Iran, Ireland, Israel, Italy, Libya, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, Norway, Oman, Panama, Philippines, Poland, Portugal, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey, Thailand, UAE, and United Kingdom.

device · product 44 of 62

Palindrome HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 33cm Item Code: 8888145050C

Z-1895-2015
Recall number
Z-1895-2015
Initiated
April 23, 2015
Classification
Class II
Status
Terminated
Recalling firm
Covidien LLC
Quantity
72,363 US - 24,631 Internationally

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
may not meet antimicrobial specification

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Catheters may not meet antimicrobial specification

Code information

Item codes identified with an expiry date of February 2018 and earlier

Distribution pattern

Worldwide Distribution - US (nationwide) and Internationally to Argentina, Austria, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Greece, Hong, Kong, India, Iran, Ireland, Israel, Italy, Libya, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, Norway, Oman, Panama, Philippines, Poland, Portugal, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey, Thailand, UAE, and United Kingdom.

device · product 45 of 62

Palindrome HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 33cm Item Code: 8888145050C

Z-1896-2015
Recall number
Z-1896-2015
Initiated
April 23, 2015
Classification
Class II
Status
Terminated
Recalling firm
Covidien LLC
Quantity
72,363 US - 24,631 Internationally

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
may not meet antimicrobial specification

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Catheters may not meet antimicrobial specification

Code information

Item codes identified with an expiry date of February 2018 and earlier

Distribution pattern

Worldwide Distribution - US (nationwide) and Internationally to Argentina, Austria, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Greece, Hong, Kong, India, Iran, Ireland, Israel, Italy, Libya, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, Norway, Oman, Panama, Philippines, Poland, Portugal, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey, Thailand, UAE, and United Kingdom.

device · product 46 of 62

Palindrome Precision HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 19cm Item Code: 8888145057CP

Z-1897-2015
Recall number
Z-1897-2015
Initiated
April 23, 2015
Classification
Class II
Status
Terminated
Recalling firm
Covidien LLC
Quantity
72,363 US - 24,631 Internationally

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
may not meet antimicrobial specification

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Catheters may not meet antimicrobial specification

Code information

Item codes identified with an expiry date of February 2018 and earlier

Distribution pattern

Worldwide Distribution - US (nationwide) and Internationally to Argentina, Austria, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Greece, Hong, Kong, India, Iran, Ireland, Israel, Italy, Libya, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, Norway, Oman, Panama, Philippines, Poland, Portugal, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey, Thailand, UAE, and United Kingdom.

device · product 47 of 62

Palindrome Precision HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 23cm Item Code: 8888145048P

Z-1898-2015
Recall number
Z-1898-2015
Initiated
April 23, 2015
Classification
Class II
Status
Terminated
Recalling firm
Covidien LLC
Quantity
72,363 US - 24,631 Internationally

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
may not meet antimicrobial specification

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Catheters may not meet antimicrobial specification

Code information

Item codes identified with an expiry date of February 2018 and earlier

Distribution pattern

Worldwide Distribution - US (nationwide) and Internationally to Argentina, Austria, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Greece, Hong, Kong, India, Iran, Ireland, Israel, Italy, Libya, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, Norway, Oman, Panama, Philippines, Poland, Portugal, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey, Thailand, UAE, and United Kingdom.

device · product 48 of 62

Palindrome Precision HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 23cm Item Code: 8888145048CP

Z-1899-2015
Recall number
Z-1899-2015
Initiated
April 23, 2015
Classification
Class II
Status
Terminated
Recalling firm
Covidien LLC
Quantity
72,363 US - 24,631 Internationally

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
may not meet antimicrobial specification

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Catheters may not meet antimicrobial specification

Code information

Item codes identified with an expiry date of February 2018 and earlier

Distribution pattern

Worldwide Distribution - US (nationwide) and Internationally to Argentina, Austria, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Greece, Hong, Kong, India, Iran, Ireland, Israel, Italy, Libya, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, Norway, Oman, Panama, Philippines, Poland, Portugal, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey, Thailand, UAE, and United Kingdom.

device · product 49 of 62

Palindrome Precision HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 8888145049P

Z-1900-2015
Recall number
Z-1900-2015
Initiated
April 23, 2015
Classification
Class II
Status
Terminated
Recalling firm
Covidien LLC
Quantity
72,363 US - 24,631 Internationally

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
may not meet antimicrobial specification

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Catheters may not meet antimicrobial specification

Code information

Item codes identified with an expiry date of February 2018 and earlier

Distribution pattern

Worldwide Distribution - US (nationwide) and Internationally to Argentina, Austria, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Greece, Hong, Kong, India, Iran, Ireland, Israel, Italy, Libya, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, Norway, Oman, Panama, Philippines, Poland, Portugal, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey, Thailand, UAE, and United Kingdom.

device · product 50 of 62

Palindrome Precision HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 8888145049CP

Z-1901-2015
Recall number
Z-1901-2015
Initiated
April 23, 2015
Classification
Class II
Status
Terminated
Recalling firm
Covidien LLC
Quantity
72,363 US - 24,631 Internationally

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
may not meet antimicrobial specification

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Catheters may not meet antimicrobial specification

Code information

Item codes identified with an expiry date of February 2018 and earlier

Distribution pattern

Worldwide Distribution - US (nationwide) and Internationally to Argentina, Austria, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Greece, Hong, Kong, India, Iran, Ireland, Israel, Italy, Libya, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, Norway, Oman, Panama, Philippines, Poland, Portugal, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey, Thailand, UAE, and United Kingdom.

device · product 51 of 62

Palindrome Precision HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 33cm Item Code: 8888145050P

Z-1902-2015
Recall number
Z-1902-2015
Initiated
April 23, 2015
Classification
Class II
Status
Terminated
Recalling firm
Covidien LLC
Quantity
72,363 US - 24,631 Internationally

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
may not meet antimicrobial specification

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Catheters may not meet antimicrobial specification

Code information

Item codes identified with an expiry date of February 2018 and earlier

Distribution pattern

Worldwide Distribution - US (nationwide) and Internationally to Argentina, Austria, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Greece, Hong, Kong, India, Iran, Ireland, Israel, Italy, Libya, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, Norway, Oman, Panama, Philippines, Poland, Portugal, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey, Thailand, UAE, and United Kingdom.

device · product 52 of 62

Palindrome Precision HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 33cm Item Code: 8888145050CP

Z-1903-2015
Recall number
Z-1903-2015
Initiated
April 23, 2015
Classification
Class II
Status
Terminated
Recalling firm
Covidien LLC
Quantity
72,363 US - 24,631 Internationally

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
may not meet antimicrobial specification

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Catheters may not meet antimicrobial specification

Code information

Item codes identified with an expiry date of February 2018 and earlier

Distribution pattern

Worldwide Distribution - US (nationwide) and Internationally to Argentina, Austria, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Greece, Hong, Kong, India, Iran, Ireland, Israel, Italy, Libya, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, Norway, Oman, Panama, Philippines, Poland, Portugal, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey, Thailand, UAE, and United Kingdom.

device · product 53 of 62

Palindrome HSI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 19cm Item Code: 8888119369

Z-1904-2015
Recall number
Z-1904-2015
Initiated
April 23, 2015
Classification
Class II
Status
Terminated
Recalling firm
Covidien LLC
Quantity
72,363 US - 24,631 Internationally

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
may not meet antimicrobial specification

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Catheters may not meet antimicrobial specification

Code information

Item codes identified with an expiry date of February 2018 and earlier

Distribution pattern

Worldwide Distribution - US (nationwide) and Internationally to Argentina, Austria, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Greece, Hong, Kong, India, Iran, Ireland, Israel, Italy, Libya, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, Norway, Oman, Panama, Philippines, Poland, Portugal, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey, Thailand, UAE, and United Kingdom.

device · product 54 of 62

Palindrome HSI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 23cm Item Code: 8888123409

Z-1905-2015
Recall number
Z-1905-2015
Initiated
April 23, 2015
Classification
Class II
Status
Terminated
Recalling firm
Covidien LLC
Quantity
72,363 US - 24,631 Internationally

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
may not meet antimicrobial specification

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Catheters may not meet antimicrobial specification

Code information

Item codes identified with an expiry date of February 2018 and earlier

Distribution pattern

Worldwide Distribution - US (nationwide) and Internationally to Argentina, Austria, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Greece, Hong, Kong, India, Iran, Ireland, Israel, Italy, Libya, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, Norway, Oman, Panama, Philippines, Poland, Portugal, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey, Thailand, UAE, and United Kingdom.

device · product 55 of 62

Palindrome HSI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 8888128459

Z-1906-2015
Recall number
Z-1906-2015
Initiated
April 23, 2015
Classification
Class II
Status
Terminated
Recalling firm
Covidien LLC
Quantity
72,363 US - 24,631 Internationally

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
may not meet antimicrobial specification

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Catheters may not meet antimicrobial specification

Code information

Item codes identified with an expiry date of February 2018 and earlier

Distribution pattern

Worldwide Distribution - US (nationwide) and Internationally to Argentina, Austria, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Greece, Hong, Kong, India, Iran, Ireland, Israel, Italy, Libya, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, Norway, Oman, Panama, Philippines, Poland, Portugal, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey, Thailand, UAE, and United Kingdom.

device · product 56 of 62

Palindrome HSI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 33cm Item Code: 8888133509

Z-1907-2015
Recall number
Z-1907-2015
Initiated
April 23, 2015
Classification
Class II
Status
Terminated
Recalling firm
Covidien LLC
Quantity
72,363 US - 24,631 Internationally

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
may not meet antimicrobial specification

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Catheters may not meet antimicrobial specification

Code information

Item codes identified with an expiry date of February 2018 and earlier

Distribution pattern

Worldwide Distribution - US (nationwide) and Internationally to Argentina, Austria, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Greece, Hong, Kong, India, Iran, Ireland, Israel, Italy, Libya, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, Norway, Oman, Panama, Philippines, Poland, Portugal, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey, Thailand, UAE, and United Kingdom.

device · product 57 of 62

Palindrome Precision HSI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 19cm Item Code: 8888119369P

Z-1908-2015
Recall number
Z-1908-2015
Initiated
April 23, 2015
Classification
Class II
Status
Terminated
Recalling firm
Covidien LLC
Quantity
72,363 US - 24,631 Internationally

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
may not meet antimicrobial specification

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Catheters may not meet antimicrobial specification

Code information

Item codes identified with an expiry date of February 2018 and earlier

Distribution pattern

Worldwide Distribution - US (nationwide) and Internationally to Argentina, Austria, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Greece, Hong, Kong, India, Iran, Ireland, Israel, Italy, Libya, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, Norway, Oman, Panama, Philippines, Poland, Portugal, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey, Thailand, UAE, and United Kingdom.

device · product 58 of 62

Palindrome Precision HSI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 23cm Item Code: 8888123409P

Z-1909-2015
Recall number
Z-1909-2015
Initiated
April 23, 2015
Classification
Class II
Status
Terminated
Recalling firm
Covidien LLC
Quantity
72,363 US - 24,631 Internationally

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
may not meet antimicrobial specification

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Catheters may not meet antimicrobial specification

Code information

Item codes identified with an expiry date of February 2018 and earlier

Distribution pattern

Worldwide Distribution - US (nationwide) and Internationally to Argentina, Austria, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Greece, Hong, Kong, India, Iran, Ireland, Israel, Italy, Libya, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, Norway, Oman, Panama, Philippines, Poland, Portugal, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey, Thailand, UAE, and United Kingdom.

device · product 59 of 62

Palindrome Precision HSI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 8888128459P

Z-1910-2015
Recall number
Z-1910-2015
Initiated
April 23, 2015
Classification
Class II
Status
Terminated
Recalling firm
Covidien LLC
Quantity
72,363 US - 24,631 Internationally

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
may not meet antimicrobial specification

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Catheters may not meet antimicrobial specification

Code information

Item codes identified with an expiry date of February 2018 and earlier

Distribution pattern

Worldwide Distribution - US (nationwide) and Internationally to Argentina, Austria, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Greece, Hong, Kong, India, Iran, Ireland, Israel, Italy, Libya, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, Norway, Oman, Panama, Philippines, Poland, Portugal, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey, Thailand, UAE, and United Kingdom.

device · product 60 of 62

Palindrome Precision HSI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 33cm Item Code: 8888133509P

Z-1911-2015
Recall number
Z-1911-2015
Initiated
April 23, 2015
Classification
Class II
Status
Terminated
Recalling firm
Covidien LLC
Quantity
72,363 US - 24,631 Internationally

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
may not meet antimicrobial specification

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Catheters may not meet antimicrobial specification

Code information

Item codes identified with an expiry date of February 2018 and earlier

Distribution pattern

Worldwide Distribution - US (nationwide) and Internationally to Argentina, Austria, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Greece, Hong, Kong, India, Iran, Ireland, Israel, Italy, Libya, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, Norway, Oman, Panama, Philippines, Poland, Portugal, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey, Thailand, UAE, and United Kingdom.

device · product 61 of 62

Palindrome SI Chronic Catheter Sport Pack 14.5 Fr x 23 cm Item Code: 8888223408

Z1855-2015
Recall number
Z1855-2015
Initiated
April 23, 2015
Classification
Class II
Status
Terminated
Recalling firm
Covidien LLC
Quantity
72,363 US - 24,631 Internationally

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
may not meet antimicrobial specification

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Catheters may not meet antimicrobial specification

Code information

Item codes identified with an expiry date of February 2018 and earlier

Distribution pattern

Worldwide Distribution - US (nationwide) and Internationally to Argentina, Austria, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Greece, Hong, Kong, India, Iran, Ireland, Israel, Italy, Libya, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, Norway, Oman, Panama, Philippines, Poland, Portugal, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey, Thailand, UAE, and United Kingdom.

device · product 62 of 62

Palindrome SI Chronic Catheter Sport Pack 14.5 Fr x 28 cm Item Code:8888228458

Z1856-2015
Recall number
Z1856-2015
Initiated
April 23, 2015
Classification
Class II
Status
Terminated
Recalling firm
Covidien LLC
Quantity
72,363 US - 24,631 Internationally

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
may not meet antimicrobial specification

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Catheters may not meet antimicrobial specification

Code information

Item codes identified with an expiry date of February 2018 and earlier

Distribution pattern

Worldwide Distribution - US (nationwide) and Internationally to Argentina, Austria, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Greece, Hong, Kong, India, Iran, Ireland, Israel, Italy, Libya, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, Norway, Oman, Panama, Philippines, Poland, Portugal, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey, Thailand, UAE, and United Kingdom.