C.R. Bard Recalls C-Max Cutting Loop Electrodes Due to Defect
C.R. Bard is recalling 70 units of C-Max Cutting Loop Electrodes because the contact part could separate, affecting device functionality.
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: The recall is classified as FDA Class II and involves a functional defect in a medical device where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
C.R. Bard, Inc. is recalling 70 units of C-Max Cutting Loop Electrodes, Storz One-Stem, 24 Fr, .014in., .35 mm, Sterile. The affected product codes are 355325, and the lot numbers are NGAQ5248 and NGAN2854.
The recall was initiated because the contact part of the device could possibly separate from the electrode, which may affect the functionality of the device. This is classified as an FDA Class II recall.
The affected units were distributed in Florida, Georgia, Louisiana, Ohio, Virginia, and Washington. Healthcare providers and patients should stop using the affected devices and contact C.R. Bard for further instructions.
The recalled product
- Product
- C-Max" Cutting Loop Electrodes, Storz One-Stem, 24 Fr, .014in., .35 mm, Sterile, Rx only, Manufactured by: C.R. Bard, Inc., Covington, GA 30014.
- Manufacturer
- C.R. Bard, Inc.
- Category
- Medical Device — Electrodes
- Affected units
- 70
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 (2)
- Product Code: 355325
- Lot Numbers: NGAQ5248 and NGAN2854
Distribution
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