FDA Device recall Z-1609-2023
3M Attest Steam Chemical Integrators, REF 1243A
- FDA Device
- Class II
- ongoing
- Published 2023-05-24
On 2023-05-24 the FDA classified a Class II recall of 3M Attest Steam Chemical Integrators, REF 1243A by 3m Health Care Business, citing 3M Attest Steam Chemical Integrators with dates of manufacture between November 6, 2022 and January 17, 2023 have an increased potential to leak ink during a sterilization cycle.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1609-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-04-06 |
| Published | 2023-05-24 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | 3m Health Care Business |
| Distribution | US |
Product
3M Attest Steam Chemical Integrators, REF 1243A
Reason
3M Attest Steam Chemical Integrators with dates of manufacture between November 6, 2022 and January 17, 2023 have an increased potential to leak ink during a sterilization cycle.
Identifiers
| code_info | UDI/DI: Pouch: 30707387785735, (Shipper: 50707387785739), Lot Numbers: EP112025, EX112025, FE112025, EE122025, EM1220…UDI/DI: Pouch: 30707387785735, (Shipper: 50707387785739), Lot Numbers: EP112025, EX112025, FE112025, EE122025, EM122025, EV122025, FD122025, EC012026, EM012026, ET012026 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1609-2023%22
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