FDA Devices Moderate Class II Ongoing

HENRY SCHEIN, CATH PACK Item No.570-2789

Reported: December 21, 2022 Initiated: November 2, 2022 #Z-0518-2023

Product Description

Reason for Recall

Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.

Details

Recalling Firm: Stradis Medical, LLC dba Stradis Healthcare
Units Affected: 100 units
Distribution: US nationwide distribution, and Canada.
Location: Peachtree Corners, GA

Frequently Asked Questions

What product was recalled? ▼

HENRY SCHEIN, CATH PACK Item No.570-2789. Recalled by Stradis Medical, LLC dba Stradis Healthcare. Units affected: 100 units.

Why was this product recalled? ▼

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on December 21, 2022. Severity: Moderate. Recall number: Z-0518-2023.

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

Explore Related Data

Vehicle Safety → Drug Information →