Home / Recalls / Vygon U.S.A. / Z-1634-2018

Z-1634-2018 Class II Terminated

Recalled by Vygon U.S.A. — Lansdale, PA

FDA device recall Z-1634-2018 was initiated by Vygon U.S.A. on February 28, 2018 and is designated Class II. Reason for recall: Potential friction holes may affect the sterility of the product. The recall status is terminated (terminated February 19, 2019). Affected quantity: 16520 total products.

Recall Details

Product Type: Devices
Report Date: May 16, 2018
Initiation Date: February 28, 2018
Termination Date: February 19, 2019
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 16520 total products

Product Description

Neonatal PICC Tray, Product Code: AMS-8010CP-1 Convenience kit for the insertion of PICCs into the vascular system.

Reason for Recall

Potential friction holes may affect the sterility of the product.

Distribution Pattern

Nationwide Distribution to states of: AZ, UT, WI, NJ, CT, TX, PA, VA, MN, MA, MO, FL, and CA.

Code Information

Lot Number: 17C060D UDI: 08498840010563

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