Cardinal Health 200, LLC Presource Kit, SMA21LPUHJ GYN Laparoscopy Pack. Convenience kit used for Laparoscopic surgery Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Presource Kit, SMA21LPUHJ GYN Laparoscopy Pack. Convenience kit used for Laparoscopic surgery
Brand
Cardinal Health 200, LLC
Lot Codes / Batch Numbers
Catalog Number: SMA21LPUHJ, Lot Number: 019693
Products Sold
Catalog Number: SMA21LPUHJ; Lot Number: 019693
Cardinal Health 200, LLC is recalling Presource Kit, SMA21LPUHJ GYN Laparoscopy Pack. Convenience kit used for Laparoscopic surgery due to Inadvertently released for distibution without sterility assurance.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Inadvertently released for distibution without sterility assurance.
Recommended Action
Per FDA guidance
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.
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 noticeDistribution
As reported by FDA
GA, IN
Page updated: Jan 10, 2026