Recalls / —

—#200099

Product

Presource Kit, SMA21LPUHJ GYN Laparoscopy Pack. Convenience kit used for Laparoscopic surgery

FDA product code

OHD — Gynecological Laparoscopic Kit

Device class

Class 2

Medical specialty

Obstetrics/Gynecology

Affected lot / code info

Catalog Number: SMA21LPUHJ; Lot Number: 019693

Why it was recalled

Inadvertently released for distibution without sterility assurance.

Root cause (FDA determination)

Process control

Action the firm took

Cardinal Health initially notified customer on 04/06/2023, via telephone, on 04/12/2023, via email and followed up with a recall notification letter on 05/05/2023. Customer was instructed to return affected product.

Recalling firm

Firm

Cardinal Health 200, LLC

Address

3651 Birchwood Dr, Waukegan, Illinois 60085-8337

Distribution

Distribution pattern

Distribution in the US to Georgia

Timeline

Recall initiated

2023-04-06

Posted by FDA

2023-06-06

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #200099. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.