Recall Z-1823-2022— CooperSurgical, Inc.

Name: FDA recall Z-1823-2022
Creator: U.S. Food and Drug Administration
Published: 2022-08-12

Class II · Ongoing

Class II FDA medical device recall by CooperSurgical, Inc., initiated 2022-08-12. It names one FDA 510(k) clearance: K121566. Product: Humidifier bottle and syringe filter kit (6 count of each) for the BT37 Mark II Benchtop Incubator (AY200246). 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..

Recalling firm: CooperSurgical, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2022-08-12
Firm location: Trumbull, CT, United States

510(k) clearances named in this recall

1 on FDA's record

K121566 — PLANER BT37 INCUBATORPlaner Plc·cleared 2012-11-29

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.