FDA Device recall Z-1137-2024
Centurion Kits, trays, and packs labeled as follows: BREAST BIOPSY KIT, REF MNS4360
- FDA Device
- Class I
- ongoing
- Published 2024-03-06
On 2024-03-06 the FDA classified a Class I recall of Centurion Kits, trays, and packs labeled as follows: BREAST BIOPSY KIT, REF MNS4360 by Medline Industries Northfield, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1137-2024 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2023-11-15 |
| Published | 2024-03-06 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Medline Industries Northfield |
| Distribution | US |
Product
Centurion Kits, trays, and packs labeled as follows: BREAST BIOPSY KIT, REF MNS4360
Reason
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.
Identifiers
| code_info | REF MNS4360, UDI/DI 10653160141716 (case), 00653160141719 (unit), Lot Numbers: 2022091690, 2022112290, 2022120990 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1137-2024%22
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