MEDLINE INDUSTRIES, LP - Northfield: Centurion Kits, trays, and packs labeled as follows: a) A C DAILY WET KIT, REF DM405A; b) BWH DAILY DRIVELINE MGMT KIT, REF DM640; c) DAILY DRIVELINE MGMT SYSTEM,

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: 113249 units Lot/code info: a) REF DM405A, UDI/DI 00653160322217 (case), 10653160322214 (unit), Lot Numbers: 2022042580, 2022070580, 2022071180, 2022071880, 2022072580, 2022080180, 2023040380, 2023050180, 2023073180, 2023102380; b) REF DM640, UDI/DI 00653160289602 (case), 10653160289609 (unit), Lot Numbers: 2022041390; c) REF DM600, UDI/DI 00653160352610 (case), 10653160352617 (unit), Lot Numbers: 2022041880, 2023081480; d) REF DM870A, UDI/DI 00653160348217 (case), 10653160348214 (unit), Lot Numbers: 2022020780; e) REF DM870A, UDI/DI 00653160352382 (case), 10653160352389 (unit), Lot Numbers: 2022041880; f) REF DT21465B, UDI/DI 00653160350005 (case), 10653160350002 (unit), Lot Numbers: 2022012550, 2022032880, 2022032980, 2022082280; g) REF DT18905, UDI/DI 00653160275063 (case), 10653160275060 (unit), Lot Numbers: 2022040590, 2022041390, 2022081990, 2023011290, 2023012490, 2023051190, 2023061290, 2023081590, 2023101790; h) REF DM610, UDI/DI 00653160294002 (case), 10653160294009 (unit), Lot Numbers: 2022050980, 2022072580, 2022072680, 2022080180, 2022080880, 2022081580, 2023050880, 2023061280, 2023072480, 2023081480, 2023082880; i) REF DT18210, UDI/DI 00653160352658 (case), 10653160352655 (unit), Lot Numbers: 2022042290; j) REF DT18695A, UDI/DI 00653160315127 (case), 10653160315124 (unit), Lot Numbers: 2022042790, 2022103190, 2023012790, 2023032490, 2023032890, 2023052690, 2023072890, 2023092190; k) REF DM630, UDI/DI 00653160288568 (case), 10653160288565 (unit), Lot Numbers: 2022033190; l) REF DM630, UDI/D

UPC codes

00653160322217, 10653160322214, 00653160289602, 10653160289609, 00653160352610, 10653160352617, 00653160348217, 10653160348214, 00653160352382, 10653160352389, 00653160350005, 10653160350002, 00653160275063, 10653160275060, 00653160294002, 10653160294009, 00653160352658, 10653160352655, 00653160315127, 10653160315124, 00653160288568, 10653160288565, 00653160352450, 10653160352457, 00653160349801, 10653160349808, 00653160352443, 10653160352440, 00653160352511, 10653160352518, 00653160307047, 10653160307044, 00653160265170, 10653160265177, 00653160350128, 10653160350125, 00653160349825, 10653160349822, 00653160348842, 10653160348849

Source

Official record: FDA (Device enforcement) ↗

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