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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) PORT REMOVAL PACK, REF DYNDA2936; b) PORT REMOVAL PACK, REF DYNDA2936H

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: 16 units Lot/code info: a) REF DYNDA2936, UDI/DI 40195327132577 (case), 10195327132576 (unit), Lot Numbers: 22FBQ167; b) REF DYNDA2936H, UDI/DI 40195327132577 (case), 10195327132576 (unit), Lot Numbers: 22FBQ167

UPC codes

40195327132577, 10195327132576

Source

Official record: FDA (Device enforcement)

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

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