MEDLINE INDUSTRIES, LP - Northfield: Medline Kits, trays, and packs labeled as follows: a) GYN LAPAROSCOPY, REF CDS984900M; b) GYN LAPAROSCOPY CDS, REF CDS983913S; c) GYN LAPAROSCOPY CDS, REF CDS98391

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: 533 units Lot/code info: a) REF CDS984900M, UDI/DI 40195327265671 (case), 10195327265670 (unit), Lot Numbers: 22KBW682; b) REF CDS983913S, UDI/DI 40195327057139 (case), 10195327057138 (unit), Lot Numbers: 22EBH289, 22EBI056, 22GBC582, 22GBH056, 22JBN751, 22NBC011; c) REF CDS983913T, UDI/DI 40195327238378 (case), 10195327238377 (unit), Lot Numbers: 22KBK694, 23BBA876, 23BBA877, 23BBN921; d) REF CDS983913U, UDI/DI 40195327403158 (case), 10195327403157 (unit), Lot Numbers: 23EBE521, 23EBK643; e) REF CDS983913V, UDI/DI 40195327417820 (case), 10195327417819 (unit), Lot Numbers: 23GBL963, 23GBO775, 23HBI553, 23IBR322

UPC codes

40195327265671, 10195327265670, 40195327057139, 10195327057138, 40195327238378, 10195327238377, 40195327403158, 10195327403157, 40195327417820, 10195327417819

Source

Official record: FDA (Device enforcement) ↗

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