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Recall Observatory FDA recall evidence

Device product

MEDLINE Kits, trays, and packs labeled as follows: a) CATH LAB CDS, REF CDS840228F; b) PEDIATRIC PORT A CATH TRAY, REF DYNDC2128B; c) PK, RADIOLOGY, REF DYNJ44087A; d) PORT ACCESS PACK-LF, REF DYNJ0352159C; DYNJ0352159D

Z-1095-2024

November 15, 2023

Class I

Product summary

Firm
MEDLINE INDUSTRIES, LP - Northfield
Event
Event 93800
Status
Ongoing
Classification
Class I
Quantity
385028 units
Official record key
device-enforcement:Z-1095-2024

Official wording

Reason: Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP and Saline Flush Syringe. Nurse Assist issued a recall due to the potential lack of sterility, which could result in the solution being non sterile.

Code information: a) REF CDS840228F, UDI/DI 40889942778547 (case), 10889942778546 (unit), Lot Numbers: 22CLA155, 22FLA788, 22GLA774, 22KLB047, 23CLA672, 23CLA832, 23ELA032, 23FLA055, 23FLA663; b) REF DYNDC2128B, UDI/DI 40195327249114 (case), 10195327249113 (unit), Lot Numbers: 22IBG388; c) REF DYNJ44087A, UDI/DI 40889942561804 (case), 10889942561803 (unit), Lot Numbers: 21112457, 22022812, 22022812, 22022812, 22094063, 22104208, 22032993, 21112457, 22104208; d) REF DYNJ0352159C, UDI/DI 40889942622581 (case), 10889942622580 (unit), Lot Numbers: 22FBH338, 22OBE815; REF DYNJ0352159D, UDI/DI 40195327196616 (case), 10195327196615 (unit), Lot Numbers: 23AME808, 23EMI159, 23FME004, 23JMJ796

Distribution pattern: Distribution US nationwide including Puerto Rico, Canada, UAE, and Panama

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    lack of sterility