PROLENE BLU 18IN(45CM) USP6-0(M0.7) S/A P-1 PRM
FDA Recall #Z-1515-2025 — Class II — March 7, 2025
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.
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
37,080 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: (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;
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated