Centurion Clamp kits recalled due to potential sterility breach risk
Medline Industries is recalling Centurion Clamp kits due to potential weak seals that could compromise sterility. Affected units were distributed nationwide and internationally.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall with theoretical risk of sterility compromise in surgical instruments. No reported illnesses or injuries documented. Elevated due to infection risk potential, but limited by lack of reported harm per the rubric.
Plain-English summary
Medline Industries, LP is recalling Centurion Clamp kits in multiple variants and product codes. The recall affects 12,980 units across various lot numbers.
The clamps may have weak seals that could compromise sterility if the seal fails. The weakness may not be detectable by users, creating a risk that the product could lose its sterile status.
The affected products have been distributed worldwide, including the United States, Panama, and Canada. Healthcare facilities should verify their inventory against the recalled lot numbers and product codes identified in the FDA notice.
Patients and healthcare providers with recalled units should stop using them immediately. Contact Medline Industries or the FDA for replacement or return instructions, and report any adverse events to FDA MedWatch.
The recalled product
- 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…
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device — Surgical Clamps
- Affected units
- 12,980
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 29 recalled by MEDLINE INDUSTRIES, LP - Northfield under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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