—#160057

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.

FDA product code: EZD — Catheter, Straight
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K000723, K122785
Affected lot / code info: Item 50610 Lots #'s: JUBT0404, JUBP0700, JUBR2498, JUBS1289

Why it was recalled

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

Root cause (FDA determination)

Process control

Action the firm took

A notification letter was sent to four hundred and fourteen (414) consignees via Federal Express on September 15, 2017. The letter explained the problem and requested return of the product. Distributors were directed to cease distribution of the recalled products and notify their customers of the recall.

Recalling firm

Firm: C.R. Bard, Inc.
Address: 8195 Industrial Blvd NE, Covington, Georgia 30014-1497

Distribution

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

Timeline

Recall initiated: 2017-09-14
Posted by FDA: 2018-04-04
Terminated: 2019-11-05
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #160057. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.