Presource Kit, SMA21LPUHJ GYN Laparoscopy Pack. Convenience kit used for Laparoscopic surgery
Reported: June 14, 2023 Initiated: April 6, 2023 #Z-1690-2023
Product Description
Presource Kit, SMA21LPUHJ GYN Laparoscopy Pack. Convenience kit used for Laparoscopic surgery
Reason for Recall
Inadvertently released for distibution without sterility assurance.
Details
- Recalling Firm
- Cardinal Health 200, LLC
- Units Affected
- 5 units
- Distribution
- Distribution in the US to Georgia
- Location
- Waukegan, IL
Frequently Asked Questions
What product was recalled? ▼
Presource Kit, SMA21LPUHJ GYN Laparoscopy Pack. Convenience kit used for Laparoscopic surgery. Recalled by Cardinal Health 200, LLC. Units affected: 5 units.
Why was this product recalled? ▼
Inadvertently released for distibution without sterility assurance.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 14, 2023. Severity: Moderate. Recall number: Z-1690-2023.
Related Recalls
FDA Devices Moderate
Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.2…
Vortex Surgical Inc. · 2026-02-11
FDA Devices Moderate
COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conju…
Beckman Coulter, Inc. · 2026-02-11
FDA Devices Moderate
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These inst…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These in…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Produc…
Fujirebio Diagnostics, Inc. · 2026-02-11