FDA Enforcement
Class II
Ongoing
PDS¿PLUS¿VIO¿30IN(75CM)¿USP6-0(M0.7)¿D/A¿C-1¿MP
Recall: Z-1513-2025
·
Reported April 9, 2025
Enforcement
- Recall Number
- Z-1513-2025
- Event ID
- 96461
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Ethicon Endo Surgery, LLC
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- April 9, 2025
- Initiation Date
- March 7, 2025
- Classification Date
- April 3, 2025
- Address
- 475C - Suite 202, Guaynabo, PR, 00969, United States
Description
PDS¿PLUS¿VIO¿30IN(75CM)¿USP6-0(M0.7)¿D/A¿C-1¿MP
Reason
Identified curing issues with the silicone during the needles manufacturing process.
Code Info
Product Code: PDP127H-14; GMDN: 47362; UDI-DI: 10705031047907; Lot number: 104M7E;
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.
Quantity
792 units