Agency classClass IIOur severity:High FDA (Devices)·Z-1308-2018·Announced 2018-04-11

C.R. Bard Recalls Magic 3 Intermittent Catheters Due to Seal Defects

C.R. Bard is recalling Magic 3 Intermittent Catheters because some units were 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 involves a medical device with a defect that compromises sterility (catheters caught in seal or cut), representing a risk of harm (infection) where specific injury reports are not detailed in the source text, fitting the 'risk-of-harm products where injury has not yet been reported' criterion.

Plain-English summary

C.R. Bard, Inc. is recalling approximately 10.9 million units of Magic 3 Intermittent Catheters (Item # 50612, 50614, and 50616). The recall covers specific lot numbers distributed nationwide across 37 states and Puerto Rico.

The recall was initiated because several instances of catheters caught in the sterile barrier seal were observed, and in some instances, the catheters were cut. This defect compromises the integrity of the sterile barrier.

Consumers should stop using the affected products and contact C.R. Bard, Inc. for instructions on return or replacement. The affected lots are listed in the official recall documentation.

The recalled product

Product: Magic 3 Intermittent Catheters- 12 Male - 30 catheters per box, each catheter is packaged in an individual pouch. Urinary catheter.
Manufacturer: C.R. Bard, Inc.
Category: Medical Device — Urinary Catheter
Hazard: sterility-compromise
physical-defect
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 # 50612 Lots #'s: JUBQ0995
JUAZ1253
JUBN0527
JUBP0065
JUBP0225
JUBP0675
JUBQ0093
JUBT1089
JUBQ1417
JUBQ1691
JUBR0232
JUAX0761
and JUAY0563 Item # 50614 Lots #'s: 53621355
JUAW0726
JUAW1103
JUAW1105
JUAW1200
JUAW1201
JUAW1209
JUAX0174

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 →

Same manufacturer · C.R. Bard, Inc.

See all →

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Same hazard · sterility compromise