C.R. Bard Recalls Magic3 Intermittent Catheters Due to Sterile Barrier Breach
C.R. Bard is recalling 8,970 Magic3 Intermittent Catheters because the sterile barrier packaging may be breached, potentially compromising sterility.
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 involves a medical device with a potential sterile barrier breach, which poses a risk of infection (harm) but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
C.R. Bard, Inc. is recalling 8,970 units of Magic3 Intermittent Catheters with Sure Grip Hydrophilic Coated Silicone Coude tip, Product Code 50614. The recall is due to a potential breach of the sterile barrier packaging. The affected catheters are packaged in film-to-film pouches, 30 per box, and are used as intermittent urinary catheters.
The affected product is identified by Lot Number 53621456. These units were distributed in the United States to the states of California, Florida, Illinois, Massachusetts, Minnesota, New Hampshire, New Jersey, New York, North Carolina, Ohio, Oklahoma, Pennsylvania, Texas, and Washington.
Consumers and healthcare facilities should stop using the affected catheters and contact C.R. Bard, Inc. for instructions on how to return the product or obtain a replacement.
The recalled product
- Product
- Magic3 Intermittent Catheter with Sure Grip Hydrophilic Coated Silicone Coude tip, Product Code 50614. The catheters are packaged in film-to-film pouches and packaged 30 per box. Used as an Intermittent Urinary Catheter
- Manufacturer
- C.R. Bard, Inc.
- Category
- Medical Device — Catheters
- Affected units
- 8,970
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 (1)
- Lot Number 53621456
Distribution
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