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U.S. Department of Health and Human Services

Class 2 Device Recall ACS Cath Lab Pack

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  Class 2 Device Recall ACS Cath Lab Pack see related information
Date Initiated by Firm March 22, 2022
Create Date May 06, 2022
Recall Status1 Open3, Classified
Recall Number Z-1040-2022
Recall Event ID 89868
Product Classification Cardiac catheterization kit - Product Code OES
Product ACS Cath Lab Pack
Code Information Model FTCL83K, Lot 982221 UDI: 00191072151360
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 2		 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 10 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.
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