Regard, Item Number: 800413005, Sterile, CV0482E- Vascular PK - Spohn
Reported: April 5, 2017 Initiated: January 9, 2017 #Z-1651-2017
Product Description
Regard, Item Number: 800413005, Sterile, CV0482E- Vascular PK - Spohn
Reason for Recall
Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.
Details
- Recalling Firm
- Resource Optimization & Innovation Llc
- Units Affected
- 164 kits
- Distribution
- US Distribution to LA and TX.
- Location
- Springfield, MO
Frequently Asked Questions
What product was recalled? ▼
Regard, Item Number: 800413005, Sterile, CV0482E- Vascular PK - Spohn. Recalled by Resource Optimization & Innovation Llc. Units affected: 164 kits.
Why was this product recalled? ▼
Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 5, 2017. Severity: Moderate. Recall number: Z-1651-2017.
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