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RecallWatchMedical Device Safety
Class IIOngoingZ-0778-2025

MEDLINE INDUSTRIES, LP - Northfield recalls Medline custom medical procedure kits labeled as: 1) OPEN HEART CDS-LF

MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesReported Jan 8, 2025 · 1 year ago
Legal News Analyst ·

Reason for recall

Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination.

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

Medline custom medical procedure kits labeled as: 1) OPEN HEART CDS-LF, REFCDS840451M; 2) NEURO PACK, REFDYNJ41516M; 3) RFD- AAA PACK, REFDYNJ54242B; 4) OPEN HEART A&B, REFDYNJ901203C; 5) OPEN HEART A&B, REFDYNJ901203D; 6) ACDF-LF, REFDYNJ906681B; 7) ACDF-LF, REFDYNJ906681C.

Lot / code information

REF
CDS840451M, UDI/DI 10195327417574 (EA) 40195327417575 (CS)
Lot #
24BLA736; 2)
REF
DYNJ41516M, UDI/DI 10193489202564 (EA) 40193489202565 (CS)
Lot #
19JKB417, 19LKA454, 20AKB109, 20DKB147, 20FKB171; 3)
REF
DYNJ54242B, UDI/DI 10195327167097 (EA) 40195327167098 (CS)
Lot #
23GBO400; 4)
REF
DYNJ901203C, UDI/DI 10889942572526 (EA) 40889942572527 (CS)
Lot #
19BKA270, 19CKC053, 19EKD526, 19FKC478, 19HKA796, 19KKA783, 19LKB868, 20BKA558, 20FKA993, 20IKA397, 20LKA831, 21BKA583, 21DKA592, 21GMB734; 5)
REF
DYNJ901203D, UDI/DI 10193489947526 (EA) 40193489947527 (CS)
Lot #
21GME287, 21JMH613, 22AMB438, 22CMD928, 22CMF425, 22EMF242 — +14 moreShow all
21GME287, 21JMH613, 22AMB438, 22CMD928, 22CMF425, 22EMF242, 22FMG716, 22GMH022, 22IMD195, 23AMB881, 23DME044, 23DME245, 23EMI884, 23HMH269, 23HMI447, 23LMB223, 24AMB281, 24CMI324, 24EMC691, 24EMI830; 6)
Show 4 more code fields
REF
DYNJ906681B, UDI/DI 10195327106881 (EA) 40195327106882 (CS)
Lot #
22FBC663, 22OBM278; 7)
REF
DYNJ906681C, UDI/DI 10195327173838 (EA) 40195327173839 (CS)
Lot #
22IBR002, 22JBV571, 22JBW937, 22KBB923, 22LBK562, 23ABC493, 23GBR644, 23IBP138, 23IBV201, 23JBK264, 23LBE604, 23LBS964, 24CBP708, 24EBA703, 24GBL458

What the firm is doing

Medline issued a MEDICAL DEVICE VOLUNTARY RECALL notice on 11/21/2024 to its consignees via US Mail and email. The notice explained the issue, potential risk to health, and requested that the affected product be quarantined. Once the response is received, Medline will provide labels to place on affected inventory, with instructions for the consignee to remove the affected component prior to using the kit.

DistributionShow details

Worldwide distribution - US Nationwide and the countries of UAE, and Canada.

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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