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Open, Classified

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

FDA Recall Z-1690-2023 · Posted 2023-06-06

Recalling FirmCardinal Health 200, LLC
Recall StatusOpen, Classified
Product CodeOHD
Date Initiated2023-04-06
Product Quantity5 units

Reason for Recall

Inadvertently released for distibution without sterility assurance.

Firm Action

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.

Root Cause

Process control

Distribution Pattern

Distribution in the US to Georgia

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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