Centurion Kits recall: Sterility Concern
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;
Why was Centurion Kits recalled?
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 should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- 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;
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Quantity
- 14234 units
- Distribution
- Distribution US nationwide including Puerto Rico, Canada, UAE, and Panama
- Recall date
- March 6, 2024
- Classification
- Class I
- Status
- Ongoing
- Agency
- FDA (device)