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

MEDLINE INDUSTRIES, LP - Northfield: MEDLINE kits and trays, labeled as: a) SUCTION CATH 10FR KIT W/SALINE, REF DYND41470SA, DYND41470SAH; b) TRACH CARE TRAY, REF DYNDA1931B, DYNDA1931BH

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 DYND41470SA, UDI/DI 40884389338705 (case), 10884389338704 (unit), Lot Numbers: 22HBD360, 22IBA256, 23ABU349, 23CBG160, 23GBV051, 23IBT355; REF DYND41470SAH; UDI/DI - same as DYND41470SA, Lot Numbers: 22HBD360, 22IBA256, 23ABU349, 23CBG160, 23GBV051, 23IBT355; b) REF DYNDA1931B, UDI/DI 40195327277360 (case), 10195327277369 (unit), Lot Numbers: 22LMC118, 22LMC126, 23EMB086; REF DYNDA1931BH, UDI/DI - same as DYNDA1931B, Lot Numbers: 22LMC118, 22LMC126, 23EMB086

UPC codes

40884389338705, 10884389338704, 40195327277360, 10195327277369

Source

Official record: FDA (Device enforcement)

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

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