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FDA (Device enforcement)Recalled 2023-11-15class i

MEDLINE INDUSTRIES, LP - Northfield: 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

Hazard

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.

Details from the source

Reason for recall: 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. Distribution: Distribution US nationwide including Puerto Rico, Canada, UAE, and Panama Quantity: 385028 units Lot/code info: 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

UPC codes

40889942778547, 10889942778546, 40195327249114, 10195327249113, 40889942561804, 10889942561803, 40889942622581, 10889942622580, 40195327196616, 10195327196615

Source

Official record: FDA (Device enforcement)

Republished from the official source above; details can change — the source record controls.

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