medical Class II Updated 2025-04-09

Ethicon Endo Surgery, LLC recalls PROLENE BLU 18IN(45CM) USP6-0(M0.7) S/A P-1 PRM

Recalled Product

PROLENE BLU 18IN(45CM) USP6-0(M0.7) S/A P-1 PRM


Hazard / Issue

Identified curing issues with the silicone during the needles manufacturing process.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: 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;
View official government recall

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