FDA Device recall Z-2639-2023
3M Attest Super Rapid 5 Steam-Plus Steam Challenge Pack, REF 41482V
- 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 5 Steam-Plus Steam Challenge Pack, REF 41482V 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-2639-2023 |
| 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 5 Steam-Plus Steam Challenge Pack, REF 41482V; 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: 50707387787276( (shipper); Lot Codes: 33P3EF, exp. 12/27/2024; 33P4ND, exp. 01/01/2025; 33P4NR, exp. 01/01/20…UDI/DI: 50707387787276( (shipper); Lot Codes: 33P3EF, exp. 12/27/2024; 33P4ND, exp. 01/01/2025; 33P4NR, exp. 01/01/2025; 33P5CA, exp. 01/03/2025; 33P5XT, exp. 01/06/2025 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2639-2023%22
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