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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 95615

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

Open FDA event record

Event summary

Timeline bucket
October 16, 2024
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
MEDLINE INDUSTRIES, LP - Northfield

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

8 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 8

MEDLINE NEXUS 19/20G CATH CONNECTOR, Medline SKU REF NEXCONNECT, Catheter Connector

Z-0508-2025
Recall number
Z-0508-2025
Initiated
October 16, 2024
Classification
Class II
Status
Ongoing
Quantity
1975 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The connectors may not allow catheters to be inserted as intended if the connector is not in the fully open position.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The connectors may not allow catheters to be inserted as intended if the connector is not in the fully open position.

Code information

UDI/DI 10193489490312 (each), 40193489490313 (case), Lot Numbers: 21ABD173, 21EBC720, 21GBG632, 21HBF316, 21IBH392, 21IBM516, 21JBJ902, 21JBP187, 22IBL115, 22KBD213, 22OBI434, 23ABA553, 23ABO991, 23BBG757, 23CBO551, 23EBT535

Distribution pattern

US Nationwide. Bermuda, Canada, Panama, UAE, US Virgin Islands

device · product 2 of 8

MEDLINE procedure kits labeled as follows: 1) COMBINED SPINAL AND EPIDURAL, REF DYNJRA1268B; 2) COMBINED SPINAL AND EPIDURAL, REF DYNJRA1268C; 3) FEMORAL BLOCK TRAY, REF DYNJRA1739A; 4) FEMORAL BLOCK TRAY, REF DYNJRA1739B; 5) 18G CPNB 20G STYLETED CATHETER, REF DYNJRA1869; 6) CONT EPID 18G NDL/20G CATH, REF DYNJRA9035; 7) TRAY 18G CPNB 20G STYLETED, REF DYNJRA9040; 8) CATHETER REINF W/ CONNECT OT, REF EPIREINF19O; 9) CATHETER REINF WITH CONNECTOR, REF EPIREINF29C; 10) CONTINUOUS EPIDURAL UPDATED, REF PAIN0384B; 11) CONT EPI 20G W/HUSTEAD, REF PAIN1069C; 12) CONTINUOUS EPIDURAL, REF PAIN1271A; 13) TRAY, CONT EPI 20G NYL W/ HUST, REF PAIN1281B; 14) CONTINUOUS EPIDURAL TRAY, REF PAIN1317; 15) 20G CONT. EPID TRAY, REF PAIN1353B; 16) CONTINUOUS EPIDURAL TRAY, REF PAIN1358; 17) TRAY, CONT EPI 20G NYL W/ HUST, REF PAIN1361; 18) JHAC CONT EPIDURAL, REF PAIN1437A; 19) CONTINUOUS EPIDURAL TRAY, REF PAIN1453B; 20) EPIDURAL CATH KIT, REF PAIN1536A; 21) CONTINUOUS EPIDURAL TRAY, REF PAIN1547; 22) EPIDURAL TRAY, REF PAIN1558; 23) CONTINUOUS EPIDURAL, REF PAIN1581A; 24) CONTINUOUS EPIDURAL TRAY, REF PAIN1587A; 25) CONTINUOUS EPIDURAL TRAY, REF PAIN1587B; 26) CONTINUOUS EPIDURAL TRAY, REF PAIN1605A; 27) CONTINUOUS EPIDURAL TRAY, REF PAIN1636; 28) EPIDURAL CATHETERIZATION KIT, REF PAIN1644A; 29) CONTINUOUS EPIDURAL TRAY, REF PAIN1667A; 30) CONT. EPIDURAL TRAY - NYLON, REF PAIN1709; 31) CONT. EPIDURAL TRAY - NYLON, REF PAIN1709A; 32) CONTINUOUS EPIDURAL, REF PAIN1766A; 33) PEDIATRIC EPIDURAL TRAY, REF PAIN1806; 34) EPIDURAL TRAY IMF 103130, REF PAIN1807; 35) CONTINUOUS EPIDURAL TRAY, REF PAIN1816; 36) CONTINUOUS EPIDURAL, REF PAIN1844; 37) CSE TRAY, REF PAIN1845; 38) BWH L&D EPIDURAL KIT, REF PAIN1846; 39) 17G CONT. EPI - MRI SAFE, REF PAIN1854; 40) 17G L&D CONT. EPIDURAL, REF PAIN1855; 41) CONTINUOUS/CSE TRAY, REF PAIN1856; 42) CONTINUOUS/CSE TRAY, REF PAIN1856A; 43) CONTINUOUS EPIDURAL TRAY, REF PAIN1864; 44) CONTINUOUS EPIDURAL TRAY, REF PAIN1864A; 45) CONTINUOUS EPIDURAL TRAY, REF PAIN1878; 46) CSE TRAY, REF PAIN1885; 47) TEAM HEALTH EPIDURAL, REF PAIN1887; 48) SOUND ANESTHESIA EPIDURAL, REF PAIN1888; 49) CONTINUOUS EPIDURAL TRAY, REF PAIN1890; 50) CONTINUOUS EPIDURAL TRAY, REF PAIN1892; 51) UAMS CONTINUOUS EPIDURAL, REF PAIN1893; 52) TRAY,CON,EPID,19G REINF,W/TUOH, REF PAIN1894; 53) CSE TRAY, REF PAIN1898; 54) CSE TRAY, REF PAIN1904; 55) 17/25G CSE TRAY, REF PAIN1919; 56) CSE TRAY, REF PAIN1920; 57) 17/25G CSE TRAY, REF PAIN1937; 58) CONTINUOUS EPIDURAL TRAY, REF PAIN1940; 59) COMBINED SPINAL EPIDURAL TRAY, REF PAIN1958; 60) REINFORCED CATH EPIDURAL TRAY, REF PAIN1967; 61) OPEN TIP EPIDURAL CATH TRAY, REF PAIN2014; 62) TRAY,CON,EPID,19G REINF,W/TUOH, REF PAIN9025; 63) TRAY,CON,EPID,19G REINF,W/O RX, REF PAIN9026; 64) CSE 17G HUSTEAD 27G WHIT W/RX, REF PAIN9028; 65) 17G CONT EPIDURAL NYLON, REF PAIN9030; 66) TRAY,CON EPID,19G REINF OPNTIP, REF PAIN9031; 67) 19G REINF CATH LIDO/NACL ONLY, REF PAIN9034; 68) 20G NYLON CATH LIDO/NACL ONLY, REF PAIN9035; 69) 17GHUST 27GWHIT LIDO/NACL ONLY, REF PAIN9036; 70) REINIF 19G EPI CATH S STERILE, REF REPICATH19; 71) CONT. EPIDURAL TRAY, REF SAMPA0105; 72) EPIDURAL CATH PACK, REF SAMPA0106; 73) CONTINUOUS EPIDURAL TRAY, REF SAMPA0110; 74) CONTINUOUS EPIDURAL TRAY, REF SAMPA0111

Z-0509-2025
Recall number
Z-0509-2025
Initiated
October 16, 2024
Classification
Class II
Status
Ongoing
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The connectors may not allow catheters to be inserted as intended if the connector is not in the fully open position.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The connectors may not allow catheters to be inserted as intended if the connector is not in the fully open position.

Code information

Codes: 1) DYNJRA1268B, UDI/DI 10193489370485 (each) 40193489370486 (case), Lot Numbers: 20FLA512, 20HLA422, 20ILA296, 20ILA327, 20LLA223, 21ALA087, 21CLA525; 2) DYNJRA1268C, UDI/DI 10193489905830 (each) 40193489905831 (case), Lot Numbers: 21ELA224, 21ELA333, 21GLA292, 21GLA895, 21HLA924, 21ILA773, 21JLA824, 22ALA237, 22BLA899, 22DLA197, 22DLA409, 22ELA583, 22ELB120, 22FLA820, 22FLB163, 22GLB081, 22HLA566, 22ILA092, 22LLA800, 23DLA368, 23FLA942, 23GLA321, 23HLA910, 23ILA593, 23JLA268; 3) DYNJRA1739A, UDI/DI 1019348992495 (each) 40193489924955 (case), Lot Numbers: 23CBE392; 4) DYNJRA1739B, UDI/DI 10195327411237 (each) 40195327411238 (case), Lot Numbers: 23FBL394, 23GBV201, 23HBG282, 23HBG968, 23IBQ191; 5) DYNJRA1869, UDI/DI 10195327018818 (each) 40195327018819 (case), Lot Numbers: 23CBE391; 6) DYNJRA9035, UDI/DI 10884389618448 (each) 40884389618449 (case), Lot Numbers: 22GBO435, 22IBI073, 23BBB167, 23BBS677, 23CBL304, 23FBI382; 7) DYNJRA9040, UDI/DI 10193489830514 (each) 40193489830515 (case), Lot Numbers: 23CBO446, 23DBK742, 23HBG091, 23HBG092; 8) EPIREINF19O, UDI/DI 10195327222970 (each) 40195327222971 (case), Lot Numbers: 22HBB281, 23EBO266, 23GBA230, 23HBN806, 23HBR131, 23HBY420; 9) EPIREINF29C, UDI/DI 10195327114367 (each) 40195327114368 (case), Lot Numbers: 22FBU886, 22HBD608, 22KBK655, 22NBE738, 23ABH589, 23DBK772, 23DBN448, 23JBU253; 10) PAIN0384B, UDI/DI 10193489926842 (each) 40193489926843 (case), Lot Numbers: 23BMC466, 23FMJ516, 23FMJ523, 23FMJ721, 23HMA617, 23LMB080, 23LMC430; 11) PAIN1069C, UDI/DI 1019532736489 (each) 40195327364893 (case), Lot Numbers: 23ELA637, 23GLA586, 23HLA616, 23JLB208; 12) PAIN1271A, UDI/DI 10193489619201 (each) 40193489619202 (case), Lot Numbers: 23BLA979; 13) PAIN1281B, UDI/DI 10195327288211 (each) 40195327288212 (case), Lot Numbers: 22KLA735, 23ALA157; 14) PAIN1317, UDI/DI 10888277797109 (each) 40888277797100 (case), Lot Numbers: 22GLA179, 22HLB332, 23CLA460, 23DLA279, 23ELB138, 23FLA944, 23GLA948, 23HLB106, 23ILA924, 23JLB213, 23KLB167; 15) PAIN1353B, UDI/DI 10193489336726 (each) 40193489336727 (case), Lot Numbers: 20ELA452; 16) PAIN1358, UDI/DI 10193489586749 (each) 40193489586740 (case), Lot Numbers: 22FLB088, 23CLA573; 17) PAIN1361, UDI/DI 10193489586848 (each) 40193489586849 (case), Lot Numbers: 22FLA642, 22GLA243, 23ILA612, 23JLA051; 18) PAIN1437A, UDI/DI 1019532713519 (each) 40195327135196 (case), Lot Numbers: 22EBA985, 23ABO995, 23KBH798, 23KBR650; 19) PAIN1453B, UDI/DI 1019532731038 (each) 40195327310388 (case), Lot Numbers: 22LLB007, 23ALA593, 23BLA987; 20) PAIN1536A, UDI/DI 10193489288582 (each) 40193489288583 (case), Lot Numbers: 23CLA081; 21) PAIN1547, UDI/DI 10193489813081 (each) 40193489813082 (case), Lot Numbers: 23BLB100, 23FLA069, 23JLA884; 22) PAIN1558, UDI/DI 10193489213584 (each) 40193489213585 (case), Lot Numbers: 23BMH883, 23GMA342, 23GMC058, 23IMC928; 23) PAIN1581A, UDI/DI 10195327351809 (each) 40195327351800 (case), Lot Numbers: 23BLB024, 23CLA024, 23ELB140; 24) PAIN1587A, UDI/DI 10193489336368 (each) 40193489336369 (case), Lot Numbers: 23BLA078, 23FLA277; 25) PAIN1587B, UDI/DI 10195327539511 (each) 40195327539512 (case), Lot Numbers: 23JLB184; 26) PAIN1605A, UDI/DI 1019348946814 (each) 40193489468145 (case), Lot Numbers: 22KLA748, 23BLA153; 27) PAIN1636, UDI/DI 10193489312720 (each) 40193489312721 (case), Lot Numbers: 22FLA297; 28) PAIN1644A, UDI/DI 10195327427863 (each) 40195327427864 (case), Lot Numbers: 23GLA589, 23HLA915, 23JLA225, 23KLA831; 29) PAIN1667A, UDI/DI 10193489472868 (each) 40193489472869 (case), Lot Numbers: 22FLB089, 23CLA442, 23ELA958, 23FLA945, 23HLA916, 23KLB169; 30) PAIN1709, UDI/DI 10193489816044 (each) 40193489816045 (case), Lot Numbers: 23CLA719; 31) PAIN1709A, UDI/DI 10195327411220 (each) 40195327411221 (case), Lot Numbers: 23ELA723, 23ILA927; 32) PAIN1766A, UDI/DI 10195327361488 (each) 40195327361489 (case), Lot Numbers: 23FLB123, 23GLA313; 33) PAIN1806, UDI/DI 10195327134563 (each) 40195327134564 (case), Lot Numbers: 22ELA290, 22FLB111; 34) PAIN1807, UDI/DI 1019532713502 (each) 40195327135028 (case), Lot Numbers: 22FLB112, 23DLA445; 35) PAIN1816, UDI/DI 10195327145453 (each) 40195327145454 (case), Lot Numbers: 22GLA509, 22GLA531; 36) PAIN1844, UDI/DI 10195327207748 (each) 40195327207749 (case), Lot Numbers: 23BLA981, 23ELB126, 23ILA404, 23ILB016; 37) PAIN1845, UDI/DI 10195327210823 (each) 40195327210824 (case), Lot Numbers: 23ELA640; 38) PAIN1846, UDI/DI 10195327211639 (each) 40195327211630 (case), Lot Numbers: 23DLA446; 39) PAIN1854, UDI/DI 10195327225858 (each) 40195327225859 (case), Lot Numbers: 22JLB193, 22LLA402; 40) PAIN1855, UDI/DI 10195327226015 (each) 40195327226016 (case), Lot Numbers: 22LLA455, 23CLA867; 41) PAIN1856, UDI/DI 10195327228996 (each) 40195327228997 (case), Lot Numbers: 22JLB162, 22LLA409; 42) PAIN1856A, UDI/DI 10195327338015 (each) 40195327338016 (case), Lot Numbers: 23HLB303; 43) PAIN1864, UDI/DI 10195327238766 (each) 40195327238767 (case), Lot Numbers: 22HLB077, 22LLA731, 23FLA012; 44) PAIN1864A, UDI/DI 10195327517090 (each) 40195327517091 (case), Lot Numbers: 23LLA277; 45) PAIN1878, UDI/DI 10195327257842 (each) 40195327257843 (case), Lot Numbers: 23ALA348, 23ELA724; 46) PAIN1885, UDI/DI 10195327269159 (each) 40195327269150 (case), Lot Numbers: 22LLA664, 23DLA281, 23ELA641; 47) PAIN1887, UDI/DI 10195327272852 (each) 40195327272853 (case), Lot Numbers: 22KLA920; 48) PAIN1888, UDI/DI 10195327272913 (each) 40195327272914 (case), Lot Numbers: 23BLA151, 23BLB105; 49) PAIN1890, UDI/DI 10195327282387 (each) 40195327282388 (case), Lot Numbers: 23BLB106; 50) PAIN1892, UDI/DI 10195327283049 (each) 40195327283040 (case), Lot Numbers: 23BLB026, 23ELB077, 23ILA928; 51) PAIN1893, UDI/DI 10195327283865 (each) 40195327283866 (case), Lot Numbers: 23BLA283, 23GLA624, 23HLA803; 52) PAIN1894, UDI/DI 10195327283896 (each) 40195327283897 (case), Lot Numbers: 23BLB107, 23ELA725, 23GLA370; 53) PAIN1898, UDI/DI 10195327297596 (each) 40195327297597 (case), Lot Numbers: 23BLA284, 23BLA726; 54) PAIN1904, UDI/DI 10195327312336 (each) 40195327312337 (case), Lot Numbers: 23ELB079, 23GLA947, 23HLA774; 55) PAIN1919, UDI/DI 10195327342807 (each) 40195327342808 (case), Lot Numbers: 23CLA461, 23GLB137, 23HLA653, 23ILA462; 56) PAIN1920, UDI/DI 10195327346072 (each) 40195327346073 (case), Lot Numbers: 23FLA827, 23HLA259; 57) PAIN1937, UDI/DI 10195327362737 (each) 40195327362738 (case), Lot Numbers: 23ELB122; 58) PAIN1940, UDI/DI 10195327365332 (each) 40195327365333 (case), Lot Numbers: 23ELB080; 59) PAIN1958, UDI/DI 10195327399986 (each) 40195327399987 (case), Lot Numbers: 23GBV335, 23IBL615; 60) PAIN1967, UDI/DI 10195327417482 (each) 40195327417483 (case), Lot Numbers: 23IDA109, 23KDB373; 61) PAIN2014, UDI/DI 10195327510763 (each) 40195327510764 (case), Lot Numbers: 23JBS142; 62) PAIN9025, UDI/DI 10193489777697 (each) 40193489777698 (case), Lot Numbers: 22FLB008, 22LLA741; 63) PAIN9026, UDI/DI 10193489777703 (each) 40193489777704 (case), Lot Numbers: 23ALA479, 23ALA534, 23ALA753, 23BLA647, 23BLB091, 23CLA295; 64) PAIN9028, UDI/DI 10193489295689 (each) 40193489295680 (case), Lot Numbers: 22GLA287, 22ILA124, 23CLA410; 65) PAIN9030, UDI/DI 10193489295641 (each) 40193489295642 (case), Lot Numbers: 22FLB009, 22HLB347, 22ILA078, 23CLA407; 66) PAIN9031, UDI/DI 10195327146429 (each) 40195327146420 (case), Lot Numbers: 22GLA057, 23ALA831, 23ELA887, 23GLA871; 67) PAIN9034, UDI/DI 10195327287757 (each) 40195327287758 (case), Lot Numbers: 23ABB439, 23ABG209, 23BBS341, 23CBO460, 23EBM262, 23EBR039, 23FBI376, 23FBI377; 68) PAIN9035, UDI/DI 10195327288006 (each) 40195327288007 (case), Lot Numbers: 23BBP889; 69) PAIN9036, UDI/DI 10195327288013 (each) 40195327288014 (case), Lot Numbers: 23BBN205, 23GBW665, 23HBQ304, 23HBU314, 23JBO472; 70) REPICATH19, UDI/DI 10193489630848 (each) 40193489630849 (case), Lot Numbers: 22ABM967, 22GBG329, 22HBO372, 23CBI450, 23GBI168, 23GBI169, 23GBI170, 23HBI971; 71) SAMPA0105, UDI/DI 10195327026240 (each) 40195327026241 (case), Lot Numbers: 21JLA580; 72) SAMPA0106, UDI/DI 10195327028169 (each) 40195327028160 (case), Lot Numbers: 21LBY057; 73) SAMPA0110, UDI/DI 10195327097004 (each) 40195327097005 (case), Lot Numbers: 22BLA107, 22CLA719, 22CLA850; 74) SAMPA0111, UDI/DI 10195327204693 (each) 40195327204694 (case), Lot Numbers: 22LLA665

Distribution pattern

US Nationwide. Bermuda, Canada, Panama, UAE, US Virgin Islands

device · product 3 of 8

MEDLINE procedure kits labeled as follows: 1) 20G EPI CATH SINGLE STERILE, REF EPICATH19 2) 20G EPI CATH SINGLE STERILE, REF EPICATH20

Z-0510-2025
Recall number
Z-0510-2025
Initiated
October 16, 2024
Classification
Class II
Status
Ongoing
Quantity
5975 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The connectors may not allow catheters to be inserted as intended if the connector is not in the fully open position.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The connectors may not allow catheters to be inserted as intended if the connector is not in the fully open position.

Code information

Codes: 1) EPICATH19, UDI/DI 10889942358311(each) 40889942358312(case), Lot Numbers: 22FBX111, 22FBY472, 23FBT886, 23GBL403, 23GBO700, 23GBO701, 23GBO702; 2) EPICATH20, UDI-DI: 10889942358328 (each) 40889942358329 (case), Lot Numbers: 22FBN457, 22HBM699, 22HBN345, 23CBF321, 23DBM670, 23FBK248, 23GBO703, 23GBO704 23GBO705, 23KBG553, 23KBS111

Distribution pattern

US Nationwide. Bermuda, Canada, Panama, UAE, US Virgin Islands

device · product 4 of 8

MEDLINE procedure kits labeled as follows: 1) ECHOSTIM BLOCK SET, REF DYNJRA9043S; 2) ULTRASOUND BLOCK PREP TRAY, REF PAIN1622A

Z-0511-2025
Recall number
Z-0511-2025
Initiated
October 16, 2024
Classification
Class II
Status
Ongoing
Quantity
3396 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The connectors may not allow catheters to be inserted as intended if the connector is not in the fully open position.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The connectors may not allow catheters to be inserted as intended if the connector is not in the fully open position.

Code information

Codes: 1) DYNJRA9043S, UDI/DI 10193489888287(each) 40193489888288(case), Lot Numbers: 23CBE390, 23CBO216, 23EBM309, 23EBP979, 23EBS281, 23GBV099, 23HBG915, 23IBG610, 23IBG611, 23JBQ712, 23KBC341; 2) PAIN1622A, UDI/DI 10193489891690 (each) 40193489891691 (case), Lot Numbers: 21ELA821, 21GLA615, 21KLA308, 22ALA608, 22CLA681, 22ELB088, 22FLB075, 22GLA543, 22KLA019, 23BLA333, 23DLA466, 23HLA896

Distribution pattern

US Nationwide. Bermuda, Canada, Panama, UAE, US Virgin Islands

device · product 5 of 8

MEDLINE procedure kits labeled as follows: 1) PERIPHERAL CONTINUOUS NERVE BL, REF PAIN1423A; 2) CONT. 20G EPI MRI COMPATIBLE, REF PAIN1470A; 3) EPIDURAL CATHETERIZATION KIT, REF PAIN1644

Z-0512-2025
Recall number
Z-0512-2025
Initiated
October 16, 2024
Classification
Class II
Status
Ongoing
Quantity
3006 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The connectors may not allow catheters to be inserted as intended if the connector is not in the fully open position.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The connectors may not allow catheters to be inserted as intended if the connector is not in the fully open position.

Code information

Codes: 1) PAIN1423A UDI-DI: 10193489201826 (each) 40193489201827 (case), Lot Numbers: 22GLA530, 23BLA921, 23DLA373, 23GLA522, 23ILA136, 23JLB217, 23KLA008; 2) PAIN1470A UDI-DI: 10193489957365 (each) 40193489957366 (case), Lot Numbers: 21JLA366, 21JLA956, 21LLA271, 22CLA831, 22DLA301, 22DLB149, 22FLA103; 3) PAIN1644 UDI-DI: 10193489331141 (each) 40193489331142 (case), Lot Numbers: 22FLA985, 23CLA104

Distribution pattern

US Nationwide. Bermuda, Canada, Panama, UAE, US Virgin Islands

device · product 6 of 8

MEDLINE procedure kits labeled as follows: 1) CONT EPI 20G W/HUSTEAD, REF PAIN1069B; 2) CSE TRAY, REF PAIN1941; 3) TRAY CON EPID 20G NYL W/TUOHY, REF PAIN9023; 4) TRAY, CONT EPI 20G NYL W/ HUST, REF PAIN1281 5) TRAY, CONT EPI 20G NYL W/ HUST, REF PAIN9024

Z-0513-2025
Recall number
Z-0513-2025
Initiated
October 16, 2024
Classification
Class II
Status
Ongoing
Quantity
3744 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The connectors may not allow catheters to be inserted as intended if the connector is not in the fully open position.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The connectors may not allow catheters to be inserted as intended if the connector is not in the fully open position.

Code information

Codes: 1) PAIN1069B UDI-DI: 10889942757381 (each) 40889942757382 (case), Lot Numbers: 22GLA433, 23CLA257; 2) PAIN1941 UDI-DI: 10195327365417 (each) 40195327365418(case), Lot Numbers: 23ELB081; 3) PAIN9023 UDI-DI: 10889942448715(each) 40889942448716 (case), Lot Numbers: 22GLA470, 22ILA287; 4) PAIN1281 UDI-DI: 10888277748408(each) 40888277748409(case), Lot Numbers: 22FLA647; 5) PAIN9024 UDI-DI: 10889942448708(each) 40889942448709(case), Lot Numbers: 22FLA675, 22GLA241, 22HLB225, 22ILA288

Distribution pattern

US Nationwide. Bermuda, Canada, Panama, UAE, US Virgin Islands

device · product 7 of 8

MEDLINE procedure kits labeled as follows: 1) NEURAXIAL KIT, REF PAIN1876A

Z-0514-2025
Recall number
Z-0514-2025
Initiated
October 16, 2024
Classification
Class II
Status
Ongoing
Quantity
360 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The connectors may not allow catheters to be inserted as intended if the connector is not in the fully open position.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The connectors may not allow catheters to be inserted as intended if the connector is not in the fully open position.

Code information

Codes: 1) PAIN1876A UDI-DI: 10195327433666 (each) 40195327433667 (case), Lot Number: 23KLA330

Distribution pattern

US Nationwide. Bermuda, Canada, Panama, UAE, US Virgin Islands

device · product 8 of 8

MEDLINE procedure kits labeled as follows: 1) L&D CONTINUOUS EPIDURAL TRAY, REF PAIN1699; 2) L&D CONTINUOUS EPIDURAL TRAY, REF PAIN1699A

Z-0515-2025
Recall number
Z-0515-2025
Initiated
October 16, 2024
Classification
Class II
Status
Ongoing
Quantity
2592 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The connectors may not allow catheters to be inserted as intended if the connector is not in the fully open position.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The connectors may not allow catheters to be inserted as intended if the connector is not in the fully open position.

Code information

Codes: 1) PAIN1699 UDI-DI: 10193489471908 (each) 40193489471909 (case), Lot Numbers: 22FLB063, 23BLB103, 23CLA768; 2) PAIN1699A UDI-DI: 10195327411107 (each) 40195327411108 (case), Lot Numbers: 23GLA369, 23ILA137

Distribution pattern

US Nationwide. Bermuda, Canada, Panama, UAE, US Virgin Islands