Centurion Kits, trays, and packs labeled as follows: a) BASIC PROCEDURE TRAY, REF MNS13600; ...
FDA Device Recall #Z-1132-2024 — Class I — November 15, 2023
Recall Summary
| Recall Number | Z-1132-2024 |
| Classification | Class I — Serious risk |
| Date Initiated | November 15, 2023 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | MEDLINE INDUSTRIES, LP - Northfield |
| Location | Northfield, IL |
| Product Type | Devices |
| Quantity | 14234 units |
Product Description
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;
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 Pattern
Distribution US nationwide including Puerto Rico, Canada, UAE, and Panama
Lot / Code Information
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
Other Recalls from MEDLINE INDUSTRIES, LP - Northfield
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2567-2025 | Class I | Medline medical convenience kits labeled as: ... | Jul 25, 2025 |
| Z-2566-2025 | Class I | Medline medical convenience kits labeled as: ... | Jul 25, 2025 |
| Z-2479-2025 | Class II | Medline Kits containing BD SureStep Foley Tray ... | Jul 23, 2025 |
| Z-2460-2025 | Class I | Medline ReNewal Reprocessed St. Jude Medical Re... | Jul 14, 2025 |
| Z-2452-2025 | Class II | The Medline General Surgery Tray is customized ... | Jul 8, 2025 |
Frequently Asked Questions
Sterility recalls for medical devices vary in severity. If you have already had a procedure using a potentially non-sterile device, contact your healthcare provider immediately — you may need monitoring for signs of infection. Symptoms to watch for include fever, redness or swelling at the surgical site, unusual pain, or discharge. For devices that have not yet been used, they should be quarantined and returned to the manufacturer per the recall notice. Non-sterile implants can cause serious infections; early detection and treatment are critical.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.