C.R. Bard Recalls Option-vf Urinary Catheters Due to Sterility Concerns
C.R. Bard is recalling 274 units of Option-vf Urinary Catheters because an FDA inspection found them to be potentially nonsterile.
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 sterile medical device found to be potentially nonsterile, which poses a risk of infection. This fits the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
C.R. Bard, Inc. is recalling 274 units of Option-vf Urinary Catheters. These are sterile, prescription-only devices intended for female use and are latex-free.
The recall was initiated after an FDA inspection determined that the catheters were potentially nonsterile. The affected products are identified by Catalog No. FV14218 and Lot Nos. P1007637, P1007638, and P1007461, with an expiration date of 08/01/2016.
The devices were distributed in the United States to the states of AL, CA, CO, FL, IL, IN, MA, MD, NJ, NY, OR, PA, TN, WA, and WI. Consumers and healthcare providers should stop using these specific lots and contact C.R. Bard for further instructions.
The recalled product
- Product
- Option-vf Urinary Catheter. Female use only. Latex Free. Sterile, Rx only.
- Manufacturer
- C.R. Bard, Inc.
- Affected units
- 274
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)
- Device Listing No.: D022512. CatalogNo.: FV14218. Lot No.: P1007637
- P1007638
- P1007461. Exp Date: 08/01/2016.
Distribution
Part of a larger recall action
This product is one of 2 recalled by C.R. Bard, Inc. 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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