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Recall Observatory FDA recall evidence

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

September 14, 2017

Class II

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

    reason.no_named_rule · v1.0.0

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