FDAFDA · Food and drugs·Recall number Z-1132-2024
Centurion Kits, trays, and packs labeled as follows: a) BASIC PROCEDURE TRAY, REF MNS13600; b) BWH DAILY DRIVELINE MGMT KIT, REF DM640A; c) CIRCUMCISION TRAY, REF CIT6180; d) INCISION & DRAINAGE TRAY, REF ID1690; e) LACERATION TRAY, REF SUT19510; f) LACERATION TRAY, REF SUT19510; g) LACERATION TRAY, REF SUT8565; h) LACERATION TRAY, REF SUT8565; i) LINE REPAIR KIT, REF MNS12045A; j) MMC DAILY DRIVELINE MGMT KIT, REF DM850A; k) NEWBORN THORACOTOMY TRAY, REF MNS3470; l) NICU STERILE CENTRAL LINE CHANGE KIT, REF DT18520A; m) OMMAYA KITS - LATEX FREE, REF HT2375; n) PEDIATRIC ULTRASOUND KIT, REF MNS12995A; o) PORT ACCESS INFUSION KIT - 1IN NEEDLE, REF DYNDC2817C; p) WOUND CLOSURE AND IRRIGATION TRAY, REF SUT14785;
Published March 6, 2024 · Recall initiated: November 15, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Distributor
- Distribution US nationwide including Puerto Rico, Canada, UAE, and Panama
- Lot
- a) MNS13600, 00653160349887 (case), 10653160349884 (unit), Lot Numbers: 2022022350, 2022041880; b) DM640A, 00653160357271 (case), 10653160357278 (unit), Lot Numbers: 2022122090, 2022122890, 2023073190; c) CIT6180, 00653160290691 (case), 10653160290698 (unit), Lot Numbers: 2023080290; d) ID1690, 10653160235903 (case), 00653160235906 (unit), Lot Numbers: 2022071390, 2022120790, 2023062690; e) SUT19510, 00653160352436 (case), 10653160352433 (unit), Lot Numbers: 2022041880, 2022071180, 2022071280; f) SUT19510, 00653160356199 (case), 10653160356196 (unit), Lot Numbers: 2022120290, 2023033090, 2023052290, 2023080190; g) SUT8565, 50653160016845 (case), 00653160016840 (unit), Lot Numbers: 2022042580; h) SUT8565, 00653160356182 (case), 10653160356189 (unit), Lot Numbers: 2023020690, 2023030390, 2023050390, 2023091890; i) MNS12045A, 00653160350340 (case), 10653160350347 (unit), Lot Numbers: 2022032850, 2022041180, 2022041280; j) DM850A, 00653160354096 (case), 10653160354093 (unit), Lot Numbers: 2022072890, 2022090690, 2022112290, 2023030390, 2023070390; k) MNS3470, 10653160106029 (case), 00653160106022 (unit), Lot Numbers: 2022031790, 2022091390, 2022110890, 2023011690, 2023052290, 2023080790; l) DT18520A, 00653160351491 (case), 10653160351498 (unit), Lot Numbers: 2022082280, 2022082980; m) HT2375, 50653160050221 (case), 00653160050226 (unit), Lot Numbers: 2023061290, 023092190; n) MNS12995A, 00653160349818 (case), 10653160349815 (unit), Lot Numbers: 2022031750, 2022031850, 2022082980; o) DYNDC2817C, 00653160348361 (case), 10653160348368 (unit), Lot Numbers: 2022012480, 2022050980; p) SUT14785, 10653160193081 (case), 00653160193084 (unit), Lot Numbers: 2022060290, 2022110490, 2023040390, 2023052490, 2023061390, 2023091490
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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