PDS¿PLUS¿VIO¿30IN(75CM)¿USP6-0(M0.7)¿D/A¿C-1¿MP
FDA Recall #Z-1513-2025 — Class II — March 7, 2025
Product Description
PDS¿PLUS¿VIO¿30IN(75CM)¿USP6-0(M0.7)¿D/A¿C-1¿MP
Reason for Recall
Identified curing issues with the silicone during the needles manufacturing process.
Recalling Firm
Ethicon Endo Surgery, LLC — Guaynabo, PR
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
792 units
Distribution
Worldwide Distribution: US (Nationwide) and OUS (Foreign) to countries of: Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Germany, India, Israel, Japan, Lithuania, Mexico, Netherlands, New Zealand, Norway, Panama, Singapore, Spain, Taiwan, Uruguay.
Code Information
Product Code: PDP127H-14; GMDN: 47362; UDI-DI: 10705031047907; Lot number: 104M7E;
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated