LACERATION TRAY , Model No SGLA07A SGLA07B-01 SGLA07B-02 SGLA07B
Reported: March 26, 2025 Initiated: February 6, 2025 #Z-1350-2025
Product Description
LACERATION TRAY , Model No SGLA07A SGLA07B-01 SGLA07B-02 SGLA07B
Reason for Recall
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
Details
- Recalling Firm
- American Contract Systems Inc
- Units Affected
- 690 kits
- Distribution
- US Nationwide distribution in the state of OH.
- Location
- Tiffin, OH
Frequently Asked Questions
What product was recalled? ▼
LACERATION TRAY , Model No SGLA07A SGLA07B-01 SGLA07B-02 SGLA07B. Recalled by American Contract Systems Inc. Units affected: 690 kits.
Why was this product recalled? ▼
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 26, 2025. Severity: Moderate. Recall number: Z-1350-2025.
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