medical Class II Updated 2024-04-10

MEDLINE INDUSTRIES, LP - Northfield recalls Centurion Clamp kits labeled as: a) STERILE BACKHAUS TOWEL

Recalled Product

Centurion Clamp kits labeled as: a) STERILE BACKHAUS TOWEL CLAMP (BTC173), Product Code 66520; b) STERILE TOWEL CLAMP, Product Code A547ST; c) ST TOWEL CLAMPS NON PERFORATING (P/S), Product Code I68080; d) STERILE TOWEL CLAMPS 5 1/2, Product Code I68085; e) STERILE TOWEL CLAMPS 5 1/2", Product Code I68095; f) ZIPSER PENIS CLAMP STERILE (ZC110), Product Code ZC110ST

Hazard / Issue

Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.

Issued by

FDA

Distribution: Nationwide (United States)

Lot/Code Info: a) 66520, UDI/DI 60653160040960 (case) 00653160040968 (each), Lot Numbers: 2023111590; b) A547ST, UDI/DI 10653160113683 (case) 00653160113686 (each), Lot Numbers: 2023020990, 2023033090, 2023060790, 2023092990; c) I68080, UDI/DI 20653160232602 (case) 00653160232608 (each), Lot Numbers: 2023072790; d) I68085, UDI/DI 30653160232616 (case) 00653160232615 (each), Lot Numbers: 2023032290, 2023071790; e) I68095, UDI/DI 20653160232695 (case) 00653160232691 (each), Lot Numbers: 2023062690; f) ZC110ST, UDI/DI 00653160258462 (case) 10653160258469 (each), Lot Numbers: 2023022490, 2023041090, 2023052290, 2023062890

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