PICC Insertion Tray, Product Code: AMS-7192CS-4 Convenience kit for the insertion of PICCs into the vascular system.
Reported: May 16, 2018 Initiated: February 28, 2018 #Z-1640-2018
Product Description
PICC Insertion Tray, Product Code: AMS-7192CS-4 Convenience kit for the insertion of PICCs into the vascular system.
Reason for Recall
Potential friction holes may affect the sterility of the product.
Details
- Recalling Firm
- Vygon U.S.A.
- Units Affected
- 16,520 total products
- Distribution
- Nationwide Distribution to states of: AZ, UT, WI, NJ, CT, TX, PA, VA, MN, MA, MO, FL, and CA.
- Location
- Lansdale, PA
Frequently Asked Questions
What product was recalled? ▼
PICC Insertion Tray, Product Code: AMS-7192CS-4 Convenience kit for the insertion of PICCs into the vascular system.. Recalled by Vygon U.S.A.. Units affected: 16,520 total products.
Why was this product recalled? ▼
Potential friction holes may affect the sterility of the product.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 16, 2018. Severity: Moderate. Recall number: Z-1640-2018.
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