FDA Device recall Z-1123-2024
Medline Kits, trays, and packs labeled as follows: a) GYN LAPAROSCOPY, REF CDS984900M
- FDA Device
- Class I
- ongoing
- Published 2024-03-06
On 2024-03-06 the FDA classified a Class I recall of Medline Kits, trays, and packs labeled as follows: a) GYN LAPAROSCOPY, REF CDS984900M 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-1123-2024 |
| 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
Medline Kits, trays, and packs labeled as follows: a) GYN LAPAROSCOPY, REF CDS984900M; b) GYN LAPAROSCOPY CDS, REF CDS983913S; c) GYN LAPAROSCOPY CDS, REF CDS983913T; d) GYN LAPAROSCOPY CDS, REF CDS983913U; e) GYN LAPAROSCOPY CDS, REF CDS983913V
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 | a) REF CDS984900M, UDI/DI 40195327265671 (case), 10195327265670 (unit), Lot Numbers: 22KBW682; b) REF CDS983913S, UD…a) REF CDS984900M, UDI/DI 40195327265671 (case), 10195327265670 (unit), Lot Numbers: 22KBW682; b) REF CDS983913S, UDI/DI 40195327057139 (case), 10195327057138 (unit), Lot Numbers: 22EBH289, 22EBI056, 22GBC582, 22GBH056, 22JBN751, 22NBC011; c) REF CDS983913T, UDI/DI 40195327238378 (case), 10195327238377 (unit), Lot Numbers: 22KBK694, 23BBA876, 23BBA877, 23BBN921; d) REF CDS983913U, UDI/DI 40195327403158 (case), 10195327403157 (unit), Lot Numbers: 23EBE521, 23EBK643; e) REF CDS983913V, UDI/DI 40195327417820 (case), 10195327417819 (unit), Lot Numbers: 23GBL963, 23GBO775, 23HBI553, 23IBR322 |
|---|
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-1123-2024%22
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