Z-1515-2025 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- April 9, 2025
- Initiation Date
- March 7, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 37,080 units
Product Description
PROLENE BLU 18IN(45CM) USP6-0(M0.7) S/A P-1 PRM
Reason for Recall
Identified curing issues with the silicone during the needles manufacturing process.
Distribution Pattern
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: (1) 8706H-15, (2) 8711H-16; GMDN: 13909; UDI-DI: (1) 10705031019430, (2) 10705031019560; Lot number: 104E88, 104E89, 1047TZ, 104BQ0, 104DA2, 104JAR, 104JPJ, 104SES, 104KHD, 104SER;