Procedure Kit. Catalog Numbers K12-04830B and K12-YP030A
Reported: November 30, 2016 Initiated: September 23, 2016 #Z-0635-2017
Product Description
Procedure Kit. Catalog Numbers K12-04830B and K12-YP030A
Reason for Recall
Merit Medical Systems, Inc. announces a voluntary field action for various Merit Medical Procedure Kits due to a compromised sterile barrier.
Details
- Recalling Firm
- Merit Medical Systems, Inc.
- Units Affected
- 53 units
- Distribution
- Nationwide to VA, UT, and NC. Other foreign consignee Japan. No Canadian and VA/govt/military consignees.
- Location
- South Jordan, UT
Frequently Asked Questions
What product was recalled? ▼
Procedure Kit. Catalog Numbers K12-04830B and K12-YP030A. Recalled by Merit Medical Systems, Inc.. Units affected: 53 units.
Why was this product recalled? ▼
Merit Medical Systems, Inc. announces a voluntary field action for various Merit Medical Procedure Kits due to a compromised sterile barrier.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 30, 2016. Severity: Moderate. Recall number: Z-0635-2017.
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