MEDLINE INDUSTRIES, LP - Northfield: Centurion Kits, trays, and packs labeled as follows: a) DIALYSIS ACCESSORY PACK W/O CATHETER, REF MNS10750A; b) DIALYSIS ON KIT, REF DT21235A; c) INFUSA PORT KIT,

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: 10391 units Lot/code info: a) REF MNS10750A, UDI/DI 00653160348286 (case), 10653160348283 (unit), Lot Numbers: 2022032150, 2022053150, 2022061750, 2022073050; b) REF DT21235A, UDI/DI 00653160348453 (case), 10653160348450 (unit), Lot Numbers: 2022012701; c) REF DYNDC3166A, UDI/DI 00653160350111 (case), 10653160350118 (unit), Lot Numbers: 2022021150, 2022031450, 2022031850

UPC codes

00653160348286, 10653160348283, 00653160348453, 10653160348450, 00653160350111, 10653160350118

Source

Official record: FDA (Device enforcement) ↗

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