Device 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 incontinence, voiding dysfunction, and surgical procedures.
Z-1307-2018
Product summary
- Firm
- C.R. Bard, Inc.
- Event
- Event 78642
- Status
- Terminated
- Classification
- Class II
- Quantity
- 44640.0 units
- Official record key
device-enforcement:Z-1307-2018
Official wording
Reason: Several instances of a catheter caught in the sterile barrier seal and in some instances cut catheters were observed.
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
Derived failure modes
-
Unknown
Several instances of a catheter caught in the sterile barrier seal and in some instances cut catheters were observed.