PlainRecalls
FDA Devices Moderate Class II Ongoing

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

Reported: April 10, 2024 Initiated: February 23, 2024 #Z-1440-2024

Product Description

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 for Recall

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.

Details

Units Affected
12980 units
Distribution
Worldwide distribution - US Nationwide and the countries of Panama, Canada.
Location
Northfield, IL

Frequently Asked Questions

What product was recalled?
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. Recalled by MEDLINE INDUSTRIES, LP - Northfield. Units affected: 12980 units.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on April 10, 2024. Severity: Moderate. Recall number: Z-1440-2024.