Medline CirClamp Surgical Clamp Recalled for Incorrect Assembly
Medline is recalling 106 units of Centurion Sterile CirClamp with 1.45cm bell due to kits containing an incorrect subassembly that results in incorrect bell and base size.
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 medical device recall with a manufacturing defect affecting device specifications. No illnesses or injuries reported, but the defect represents a risk-of-harm product (surgical instrument with incorrect sizing components) where injury has not yet been reported.
Plain-English summary
Medline Industries is recalling 106 units of Centurion Sterile CirClamp with 1.45cm Bell (Reorder CR3145K) distributed nationwide across the United States. The affected lot is #2022032501 with an expiration date of 2026-12-31.
The affected kits contain CirClamp subassembly 345CRSAK, which results in the kits having an incorrect bell and base size. This manufacturing defect creates a discrepancy in the product specifications.
Healthcare providers and facilities should immediately stop using any affected units and contact Medline Industries for replacement or disposal instructions.
The recalled product
- Product
- Centurion Sterile CirClamp with 1.45cm Bell Reprocessed, Reorder CR3145K, 1 per package, 12 per case.
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device — Surgical Clamp
- Affected units
- 106
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 (3)
- Lot #2022032501
- exp. 2026-12-31
- UDI-DI - (01)10653160312956
Distribution
Distributed nationwide across the United States.
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