Z-1690-2023Class II

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

Name: Z-1690-2023 Presource Kit, SMA21LPUHJ GYN Laparoscopy Pack. Convenience kit used for Laparoscopic surgery
Creator: Cardinal Health 200, LLC
Published: 2023-04-06
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2023-04-06 / Open, Classified / root cause: manufacturing process

FDA source

Cardinal Health 200, LLC began a recall of Presource Kit, SMA21LPUHJ GYN Laparoscopy Pack. Convenience kit used for Laparoscopic surgery on 2023-04-06. FDA classified it as Class II and gives the reason as "Inadvertently released for distibution without sterility assurance". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1690-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-04-06
Posted: 2023-06-06
Recalling firm: Medtronic, Inc.
Product: Presource Kit, SMA21LPUHJ GYN Laparoscopy Pack. Convenience kit used for Laparoscopic surgery
Product code: OHD Gynecological Laparoscopic Kit
Reason for recall: Inadvertently released for distibution without sterility assurance.
Root cause tag: manufacturing process
FDA root cause: Process control
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.
Quantity in commerce: 5 units
Distribution: Distribution in the US to Georgia
Product codes and lots: Catalog Number: SMA21LPUHJ; Lot Number: 019693

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1690-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1690-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-06-14	2023-06-06

Product code OHD

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)