Centurion Clamp kits labeled as: a) STERILE BACKHAUS TOWEL CLAMP (BTC173), Product Code 66520; b) STERILE TOWEL CLAMP... — FDA record Z-1440-2024

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Feb 23, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

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
Reason
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.
Classification
Class II
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield
Quantity
12980 units
Agency-reported status
Ongoing
Source record identifier
Z-1440-2024

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label fieldDetails supplied by the agency
Lot, code or applicabilitya) 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

Match all identifying details in the current notice. A brand name alone is not enough.

Distribution

Worldwide distribution - US Nationwide and the countries of Panama, Canada.

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Report date
Apr 10, 2024
Recall initiation date
Feb 23, 2024
Center classification date
Mar 29, 2024

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

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