The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0600-2017·Announced 2016-11-23

C.R. Bard Recalls Misbranded Antibacterial Intermittent Catheters

C.R. Bard is recalling 10,290 units of Magic3 catheters labeled as hydrophilic but lacking the coating.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the source text explicitly states the issue is misbranding (labeling error) and does not report any illnesses or injuries, fitting the criteria for a moderate severity labeling error.

Plain-English summary

C.R. Bard, Inc. is recalling 10,290 units of Magic3 Antibacterial Hydrophilic Intermittent Catheters, Male 14 Fr. (30/Box), Sterile. The recall is due to misbranding; the products are labeled as having a hydrophilic coating, but they are actually Antibacterial Intermittent Catheters without the hydrophilic coating.

The affected units have Product Code 53514, Lot number 53622813, and an expiration date of 30Sep2017. These devices were distributed nationwide in California, Florida, Illinois, Indiana, Minnesota, Missouri, North Carolina, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Texas, and Utah.

The catheters are intended for urinary bladder drainage in adults requiring catheterization for incontinence, voiding dysfunction, or surgical procedures. The source text does not report any illnesses or injuries associated with this recall. Consumers and healthcare providers should stop using the affected units and contact C.R. Bard for instructions on return or replacement.

The recalled product

Product
Magic3 Antibacterial Hydrophilic Intermittent Catheter, Male 14 Fr. (30/Box), Sterile Product Usage: The catheter is an all silicone, single lumen, drainage tube with drainage eyes at the proximal end and a tapered funnel at the distal end. The outer surface of the catheter…
Manufacturer
C.R. Bard, Inc.
Category
Medical Device — Urological Catheters
Hazard
Affected units
10,290

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)

  • Product Code: 53514
  • Lot number: 53622813
  • Exp. Date: 30Sep2017.

Distribution

Distributed nationwide across the United States.

The notice also names 14 states specifically:

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