1) ACS Spine Pack 2) ACS Lumbar/Back Set Up Tray
- Company
- American Contract Systems, Inc.
- Recall Initiated
- March 22, 2022
- Recall Number
- Z-1036-2022
- Quantity
- 72 packs
- Firm Location
- Kansas City, MO
Reason for Recall
Product was sterilized with a higher than specification EO concentration.
Distribution
US Nationwide distribution in the states of IL, MO, NE, and TX.
Lot / Code Info
1) ACS Spine Pack - Model LOSP35D, Lot 966221; UDI 00191072154613 2) ACS Lumbar/Back Set Up Tray - Model SALB85AG, Lot 973221; UDI: 00191072127280
Root Cause
Process control
Action Taken
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.