Class 2 Device Recall Planer BT37 Incubator

• Date Initiated by Firm: August 12, 2022
• Date Posted: September 28, 2022
• Recall Status: Open, Classified
• Recall Number: Z-1823-2022
• Recall Event ID: 90782
• 510(K)Number: K121566
• Product Classification: Accessory, assisted reproduction - Product Code MQG
• Product: Humidifier bottle and syringe filter kit (6 count of each) for the BT37 Mark II Benchtop Incubator (AY200246)
• Code Information: Lot Numbers 18-1265 18-1268 18-1268 / G004639 G004637 G004638 G004639
• FEI Number: 1216677
• Recalling Firm/ Manufacturer: CooperSurgical, Inc.; 95 Corporate Dr; Trumbull CT 06611-1350
• For Additional Information Contact: Customer Service; 203-601-5200 Ext. 03300
• Manufacturer 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.
• FDA Determined Cause: Under Investigation by firm
• Action: On August 12, 2022, the firm notified customers via an Urgent Medical Device Safety Notice. Customers were instructed to quarantine affected product in their inventory. Once customers complete and return the Acknowledgement and Receipt Form attached to the recall letter, the firm will arrange for the affected product to be returned at no cost. Customers will receive credit for returned affected product. CooperSurgical may be reached at 203-601-5200 ext. 03300 or recall@coopersurgical.com.
• Quantity in Commerce: 5,182 kits
• Distribution: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = MQG