Recall Z-1036-2022
American Contract Systems, Inc. · initiated March 22, 2022
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
1) ACS Spine Pack 2) ACS Lumbar/Back Set Up Tray
Codes / lots: 1) ACS Spine Pack - Model LOSP35D, Lot 966221; UDI 00191072154613 2) ACS Lumbar/Back Set Up Tray - Model SALB85AG, Lot 973221; UDI: 00191072127280
Reason for recall
Product was sterilized with a higher than specification EO concentration.
FDA-determined 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.
Details
- Recall number
- Z-1036-2022
- Initiated
- March 22, 2022
- Product code
- OJG – Neurological Tray
- Quantity
- 72 packs
- Distribution
- US Nationwide distribution in the states of IL, MO, NE, and TX.
- Recalling firm
- American Contract Systems, Inc., Kansas City, MO
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1037-2022 Class II | 1) ACS Arthroscopy Kit 2) ACS Knee Kit 3) ACS Hand PackProduct was sterilized with a higher than specification EO concentration. | 03/22/2022Open, Classified |
| Z-1038-2022 Class II | ACS IR - Angio PackProduct was sterilized with a higher than specification EO concentration. | 03/22/2022Open, Classified |
| Z-1039-2022 Class II | ACS Lap Chole PackProduct was sterilized with a higher than specification EO concentration. | 03/22/2022Open, Classified |
| Z-1040-2022 Class II | ACS Cath Lab PackProduct was sterilized with a higher than specification EO concentration. | 03/22/2022Open, Classified |