PlainRecalls
FDA Devices Moderate Class II Terminated

PICC Tray, Product Code: AMS-9093CP Convenience kit for the insertion of PICCs into the vascular system.

Reported: May 16, 2018 Initiated: February 28, 2018 #Z-1637-2018

Product Description

PICC Tray, Product Code: AMS-9093CP 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
16520 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 Tray, Product Code: AMS-9093CP Convenience kit for the insertion of PICCs into the vascular system.. Recalled by Vygon U.S.A.. Units affected: 16520 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-1637-2018.