The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1431-2021·Announced 2021-04-28

Bard Clean-Cath Intermittent Catheter Recalled for Packaging and Tip Defects

C.R. Bard is recalling 9,800 units of Bard Clean-Cath Intermittent Catheters because the catheter tip was cut off and the packaging was not fully sealed.

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, and the source text does not report any illnesses, injuries, or hospitalizations. The hazard is a physical defect (missing tip, unsealed packaging) without reported harm, fitting the Moderate criteria for low-risk contamination or voluntary precautionary recalls.

Plain-English summary

C.R. Bard, Inc. is recalling 9,800 units of Bard Clean-Cath Intermittent Catheters, 12 French female length. The recall was initiated because the device catheter tip was cut off (no tip) and the product packaging was not fully sealed.

The affected product is identified by Catalog No. 420712, Lot No. NGDY1813, and UDI (GTIN) (01)00801741038730(17)241130(10), with an expiration date of 11/30/2024. The product was distributed worldwide, including the United States, Australia, and Canada.

Consumers and healthcare providers should stop using the affected catheters and contact C.R. Bard, Inc. for further instructions or a replacement.

The recalled product

Product
Bard Clean-Cath Intermittent Catheter, 12 French female length (catheter, urological) - Product Usage: for urological use only.
Manufacturer
C.R. Bard, Inc.
Category
Medical Device — Urological Catheter
Hazard
Affected units
9,800

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 (2)

  • Cat. No. 420712/Lot No. NGDY1813/ UDI (GTIN) (01)00801741038730(17)241130(10)
  • Exp. Date 11/30/2024

Distribution

Distributed nationwide across the United States.

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