Z-1823-2022 Class II Ongoing
FDA device recall Z-1823-2022 was initiated by CooperSurgical, Inc. on Aug 12, 2022 and is designated Class II. Reason for recall: 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… The recall status is ongoing. Affected quantity: 5,182 kits.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 5, 2022
- Initiation Date
- Aug 12, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5,182 kits
Product Description
Humidifier bottle and syringe filter kit (6 count of each) for the BT37 Mark II Benchtop Incubator (AY200246)
Reason for Recall
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.
Distribution Pattern
Domestic distribution to the following states: 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 Foreign distribution to Barbados, Canada, Chile, Micronesia Federate, and Panama.
Code Information
Lot Numbers 18-1265 18-1268 18-1268 / G004639 G004637 G004638 G004639
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1823-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026