The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1307-2018·Announced 2018-04-11

C.R. Bard Recalls HydroSil Gripper Intermittent Catheters Due to Seal Defects

C.R. Bard is recalling specific lots of HydroSil Gripper 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 (cut catheters) which poses a risk of harm (infection) to patients, but the source text does not report any specific illnesses or injuries, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

C.R. Bard, Inc. is recalling 44,640 units of HydroSil Gripper Intermittent Catheters, 10-inch lengths, 30 catheters per box. The affected product is identified by Item 50610 and Lots JUBT0404, JUBP0700, JUBR2498, and JUBS1289. These catheters are intended for urinary bladder drainage in patients requiring catheterization for management of incontinence, voiding dysfunction, and surgical procedures.

The recall was initiated because several instances of catheters caught in the sterile barrier seal were observed, and in some instances, cut catheters were found. This defect compromises the integrity of the sterile barrier, which is critical for preventing infection during use.

The affected units were distributed nationwide in the states of AK, AL, AR, AZ, CA, FL, GA, HI, IA, ID, KS, KY, MD, ME, MI, MN, MO, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, including Puerto Rico. Consumers and healthcare providers should stop using the affected lots and contact C.R. Bard for further instructions.

The recalled product

Product
HydroSil Gripper Intermittent Catheters- 10" lengths - 30 catheters per box, each catheter is packaged in an individual pouch. MGC3 Product Usage Intermittent catheters are intended for urinary bladder drainage in patients requiring catheterization for management of…
Manufacturer
C.R. Bard, Inc.
Category
Medical Device — Catheters
Hazard

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 (4)

  • Item 50610 Lots #'s: JUBT0404
  • JUBP0700
  • JUBR2498
  • JUBS1289

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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