Recalls / —

—#192766

Product

ACS Lap Chole Pack

FDA product code

FDE — Laparoscopy Kit

Device class

Class 2

Medical specialty

Gastroenterology, Urology

Affected lot / code info

Model BLLC42M, Lot 643211 UDI: 00191072152473

Why it was recalled

Product was sterilized with a higher than specification EO concentration.

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm

American Contract Systems, Inc.

Address

2610 Ne Industrial Dr, Ste 220, Kansas City, Missouri 64117-2648

Distribution

Distribution pattern

US Nationwide distribution in the states of IL, MO, NE, and TX.

Timeline

Recall initiated

2022-03-22

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #192766. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.