FDA Device recall Z-2638-2023
3M Attest Super Rapid Readout Steam Challenge Pack, REF 1496V
- FDA Device
- Class II
- ongoing
- Published 2023-10-04
On 2023-10-04 the FDA classified a Class II recall of 3M Attest Super Rapid Readout Steam Challenge Pack, REF 1496V by 3m Health Care Business, citing specific lots of 3M Attest Super Rapid Readout Biological Indicators (1492V), 3M Attest Super Rapid 5 Steam-Plus Challenge (41482V, 41482VF), and 3M Attest Super Rapid Readout Ste….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2638-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-08-22 |
| Published | 2023-10-04 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | 3m Health Care Business |
| Distribution | US |
Product
3M Attest Super Rapid Readout Steam Challenge Pack, REF 1496V; designed to qualify and monitor dynamic-air removal steam sterilization processes
Reason
Specific lots of 3M Attest Super Rapid Readout Biological Indicators (1492V), 3M Attest Super Rapid 5 Steam-Plus Challenge (41482V, 41482VF), and 3M Attest Super Rapid Readout Steam Challenge (1496V) may contain biological indicators with a cap that melts, deforms and/or cracks following a steam sterilization cycle of 132¿C and 135¿C.
Identifiers
| code_info | UDI/DI: 50707387762983( (shipper); Lot codes: 33P4NJ, exp. 01/01/2025; 33P56T, exp. 01/02/2025 |
|---|
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-2638-2023%22
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