Surgical Centurion CirClamp Recalled for Incorrect Subassembly Size
Medline Industries is recalling 162 units of Centurion CirClamp surgical devices due to incorrect subassembly size. The defect could affect proper device function during surgical use.
What this means for you
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: The FDA classified this as a Class II recall. Although no injuries or illnesses have been reported, the incorrect size of a surgical instrument poses a risk of patient harm if used in procedures. The rubric identifies risk-of-harm products where injury has not yet been reported as High (3).
Plain-English summary
Medline Industries, LP is recalling 162 units of the Centurion CirClamp with 1.3cm Bell & Insert (Reorder #CR230K, Lot #2022070590, expiration date 2026-08-31) due to an incorrect size of the CirClamp subassembly found in the kit.
The incorrect size of the subassembly could affect the proper fit and function of the device during surgical use, potentially compromising the intended surgical outcome.
The affected devices were distributed nationwide in California and Texas. No distribution to government, military, or foreign entities has been reported.
Healthcare facilities and professionals who have received this device should stop use immediately and contact Medline Industries for replacement. Report any adverse events related to this recall to the FDA.
The recalled product
- Product
- Centurion CirClamp with 1.3cm Bell & Insert Reprocessed, Reorder #CR230K, Sterile.
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- surgical-device-defect
- sizing-error
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 #2022070590
- Exp. 2026-08-31
- UDI (01)10653160312895(10)2022070590(17)260831.
Distribution
Distributed nationwide across the United States.
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