FDA Device recall Z-3071-2024
ANESTHESIA TURNOVER KIT, Pack Number DYNJAA0377
- FDA Device
- Class II
- ongoing
- Published 2024-09-18
On 2024-09-18 the FDA classified a Class II recall of ANESTHESIA TURNOVER KIT, Pack Number DYNJAA0377 by Medline Industries Northfield, citing A non-sterile Mastisol component, which was not labeled as being sterile or non-sterile, was placed in the non-sterile portion of certain sterile convenience kits and distributed.….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3071-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-06-18 |
| Published | 2024-09-18 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Medline Industries Northfield |
| Distribution | CA, IL, TX |
Product
ANESTHESIA TURNOVER KIT, Pack Number DYNJAA0377
Reason
A non-sterile Mastisol component, which was not labeled as being sterile or non-sterile, was placed in the non-sterile portion of certain sterile convenience kits and distributed. In the event that the user assumes sterility during its use, there is an increased risk of patient infection.
Identifiers
| code_info | UDI/DI Case 40195327231126, UDI/DI Each 10195327231125; Lot Numbers: 22LBM357 |
|---|
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-3071-2024%22
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