Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1823-2022 — Humidifier bottle and syringe filter kit (6 count of each) for the BT37 Mark II Benchtop Incubator (AY200246)

U.S. FDA — Device Enforcement · United States · 2022-08-12 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1823-2022
Date of alert
2022-08-12
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
CooperSurgical, Inc.
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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