American Contract Systems, Inc. ACS IR - Angio Pack Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
ACS IR - Angio Pack
Brand
American Contract Systems, Inc.
Lot Codes / Batch Numbers
Model JEIR37H, Lot 657211 UDI: 00191072151612
Products Sold
Model JEIR37H, Lot 657211 UDI: 00191072151612
American Contract Systems, Inc. is recalling ACS IR - Angio Pack due to Product was sterilized with a higher than specification EO concentration.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Product was sterilized with a higher than specification EO concentration.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026