C.R. Bard, Inc.: Medical Device Recall in 2018 - (Recall #: Z-1307-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.
Product Description:

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 incontinence, voiding dysfunction, and surgical procedures.

Product Classification:

Class II

Date Initiated: September 14, 2017
Date Posted: April 11, 2018
Recall Number: Z-1307-2018
Event ID: 78642
Reason for Recall:

Several instances of a catheter caught in the sterile barrier seal and in some instances cut catheters were observed.

Status: Terminated
Product Quantity: 44640.0 units
Code Information:

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

Distribution Pattern:

US 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

Voluntary or Mandated:

Voluntary: Firm initiated