The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1309-2018·Announced 2018-04-11

C.R. Bard Recalls Personal Intermittent Catheters Due to Seal Defects

C.R. Bard is recalling Personal Intermittent Catheters because some units were found caught in the sterile barrier seal or cut.

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 is classified as FDA Class II. The hazard involves a sterile barrier defect in a medical device, which poses a risk of harm (infection) even though no specific injuries or illnesses are reported in the source text.

Plain-English summary

C.R. Bard, Inc. is recalling Personal Intermittent Catheters in 16-inch and 10-inch lengths. The recall involves 10,949,013 units distributed nationwide in the United States, including Puerto Rico. The affected products are packaged in individual pouches within boxes of 30 catheters.

The recall was initiated because several instances of catheters caught in the sterile barrier seal were observed. In some instances, the catheters were found to be cut. These defects compromise the sterile integrity of the medical device.

Consumers should stop using the affected catheters and contact C.R. Bard, Inc. for further instructions. The recall covers specific item numbers and lot numbers listed in the official FDA notice.

The recalled product

Product
Personal Intermittent Catheters- 16" and 10" lengths - 30 catheters per box, each catheter is packaged in an individual pouch, Item Numbers: 50612, 50614, 50616, 50618, 52306, 52308, 52310, 52606, 52606G, 52608, 52608G, 52610, 52610G, 53314, 53320, 53514G, 53610, 53610G…
Manufacturer
C.R. Bard, Inc.
Category
Medical Device — Catheters
Hazard
Affected units
10,949,013

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 (20)

  • Item Numbers
  • Lot Numbers: 50612
  • Lot Numbers: JUBQ0995
  • JUAZ1253
  • JUBN0527
  • JUBP0065
  • JUBP0225
  • JUBP0675
  • JUBQ0093
  • JUBT1089
  • JUBQ1417
  • JUBQ1691
  • JUBR0232
  • JUAX0761
  • JUAY0563 50614
  • Lot Numbers: JUBN0526
  • JUBR2531
  • JUBR1271
  • JUBR2565
  • JUBS2412

Distribution

Distributed nationwide across the United States.

The notice also names 37 states specifically:

Part of a larger recall action

This product is one of 3 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 3 products in this recall →

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