Option-vm Urinary Catheter. Male use only. Latex Free. recall: Sterility Concern
Option-vm Urinary Catheter. Male use only. Latex Free. Sterile, Rx only.
Why was Option-vm Urinary Catheter. Male use only. Latex Free. recalled?
During an FDA inspection it was found out that the Practical Foley Catheters to be potentially nonsterile.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Device Listing No.: D022515. CatalogNo.: MV39016. Lot No.: P1007642, P1007465, P1007466, P1007643, P1007641, P1007640, P1007468, P1007467. Exp Date: 08/01/2016.
- Product
- Option-vm Urinary Catheter. Male use only. Latex Free. Sterile, Rx only.
- Recalling firm
- C.R. Bard, Inc.
- Quantity
- 274 units
- Distribution
- US Distribution to the states of : AL, CA, CO, FL, IL, IN, MA, MD, NJ, NY, OR, PA, TN, WA, and WI.
- Recall date
- September 21, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)