Class 2 Device Recall ACS IR Angio Pack

• Date Initiated by Firm: March 22, 2022
• Create Date: May 06, 2022
• Recall Status: Open, Classified
• Recall Number: Z-1038-2022
• Recall Event ID: 89868
• Product Classification: Radiology-diagnostic kit - Product Code OIP
• Product: ACS IR - Angio Pack
• Code Information: Model JEIR37H, Lot 657211 UDI: 00191072151612
• Recalling Firm/ Manufacturer: American Contract Systems, Inc.; 2610 Ne Industrial Dr Ste 220; Kansas City MO 64117-2648
• For Additional Information Contact: Suzanne Thomas; 470-280-4277
• Manufacturer Reason for Recall: Product was sterilized with a higher than specification EO concentration.
• FDA Determined Cause: Process control
• Action: A customer letter dated 04/05/2022 was issued to impacted consignees. The letter instructs the following: 1) Review your inventory and segregate affected product. This product should not be shipped out to customers. 2) Return affected product to 2610 NE Industrial Drive, Suite 220, Kansas City, MO 64120. 3) If product was already further distributed, ensure that all downstream customers are properly notified of the recall and maintain records of effectiveness. A Field Action Response Form should be completed and returned to suzanne.thomas@hyh.com, even if you do not have product inventory.
• Quantity in Commerce: 24 packs
• Distribution: US Nationwide distribution in the states of IL, MO, NE, and TX.
• 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.