Class 2 Device Recall American Contract Systems

• Date Initiated by Firm: August 07, 2024
• Date Posted: September 24, 2024
• Recall Status: Open, Classified
• Recall Number: Z-3244-2024
• Recall Event ID: 95261
• Product Classification: Cardiovascular procedure kit - Product Code OEZ
• Product: Pacemaker, COPM11B; Medical convenience kit
• Code Information: UDI-DI: 00191072206312; Lot: 2405033; Exp: 05/03/2025
• Recalling Firm/ Manufacturer: American Contract Systems, Inc.; 2610 Ne Industrial Dr Ste 220; Kansas City MO 64117-2648
• For Additional Information Contact: Marlene Jones; 816-920-5846
• Manufacturer Reason for Recall: ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
• FDA Determined Cause: Under Investigation by firm
• Action: Owens & Minor issued an URGENT: MEDICAL DEVICE FIELD CORRECTION to its consignees on 08/07/2024 via email. The notice explained the issue, potential risk to health, and requested the following actions be taken: " -Please review your inventory, and segregate and quarantine all affected Trays. If any of the affected trays identified above were further distributed, please ensure all end-users are appropriately notified and maintain records of effectiveness. - Owens & Minor issued an URGENT: MEDICAL DEVICE FIELD CORRECTION to its consignees on 08/07/2024 via email. The notice explained the issue, potential risk to health, and requested the following actions be taken: " Please review your inventory, and segregate and quarantine all affected Trays. If any of the affected trays identified above were further distributed, please ensure all end-users are appropriately notified and maintain records of effectiveness. - Discard all affected kits and document on the enclosed Response Form."
• Quantity in Commerce: 3 units
• Distribution: US Nationwide distribution in the states of MO, MN, MA, OH, NE.
• 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.