The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2831-2016·Announced 2016-09-21

C.R. Bard Recalls Option-vm Urinary Catheters Due to Sterility Concerns

C.R. Bard is recalling 274 units of Option-vm Urinary Catheters because an FDA inspection found them potentially nonsterile. The devices were distributed to 15 states.

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 sterility failure, which poses a risk of infection. Per the rubric, this is classified as High because it is a risk-of-harm product where injury has not yet been reported.

Plain-English summary

C.R. Bard, Inc. is recalling 274 units of Option-vm Urinary Catheters. These are sterile, prescription-only devices intended for male use and are latex-free. The recall was initiated after an FDA inspection revealed that the catheters were potentially nonsterile.

The affected devices are identified by Device Listing No. D022515, Catalog No. MV39016, and expiration date 08/01/2016. Specific lot numbers involved include P1007642, P1007465, P1007466, P1007643, P1007641, P1007640, P1007468, and P1007467.

The products were distributed in the United States to the states of Alabama, California, Colorado, Florida, Illinois, Indiana, Massachusetts, Maryland, New Jersey, New York, Oregon, Pennsylvania, Tennessee, Washington, and Wisconsin. Healthcare providers and patients should stop using these devices and contact C.R. Bard for further instructions.

The recalled product

Product
Option-vm Urinary Catheter. Male use only. Latex Free. Sterile, Rx only.
Manufacturer
C.R. Bard, Inc.
Category
Medical Device — Urinary Catheter
Hazard
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 (8)

  • Device Listing No.: D022515. CatalogNo.: MV39016. Lot No.: P1007642
  • P1007465
  • P1007466
  • P1007643
  • P1007641
  • P1007640
  • P1007468
  • P1007467. Exp Date: 08/01/2016.

Distribution

Distributed in 15 states:

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.

See all 2 products in this recall →

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