FDA Device recall Z-1822-2022
Humidifier bottle and syringe filter kit (6 count of each) for the BT37 Mark I Benchtop Incubator (AY102295)
- FDA Device
- Class II
- ongoing
- Published 2022-10-05
On 2022-10-05 the FDA classified a Class II recall of Humidifier bottle and syringe filter kit (6 count of each) for the BT37 Mark I Benchtop Incubator (AY102295) by Coopersurgical, citing there is a potential breach to the sterile barrier containing the Humidifier Bottles due to the packaging of the filter box located inside the bottle packaging. Damage to the ster….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1822-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-08-12 |
| Published | 2022-10-05 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Coopersurgical |
| Distribution | AL, AZ, CA, CT, DE, FL, GA, HI, IL, KS, MA, MI, MN, MO, NJ, NY, OH, OR, SC, TX, VA, VT, WA, WI, WV |
Product
Humidifier bottle and syringe filter kit (6 count of each) for the BT37 Mark I Benchtop Incubator (AY102295). The Mark I model is no longer produced, but the legacy humidifier bottle component design can also be used with the BT37 Mark II Benchtop Incubator.
Reason
There is a potential breach to the sterile barrier containing the Humidifier Bottles due to the packaging of the filter box located inside the bottle packaging. Damage to the sterile barrier may result in use of an unsterilized device, which may cause contamination and degradation or loss of embryo during incubation.
Identifiers
| code_info | Lot Numbers 05593V291121 18-1192 1812-68 18-1268 G000575 G003811 G003893 G004517 G004874 G005109 G005476 G00572…Lot Numbers 05593V291121 18-1192 1812-68 18-1268 G000575 G003811 G003893 G004517 G004874 G005109 G005476 G005723 E160415 Expiration date range: 27 Jun 2022 to 07 Dec 2024 |
|---|
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-1822-2022%22
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