Home / Recalls / Medical Devices
C.R. Bard, Inc. recalls Personal Intermittent Catheters- 16" and 10" lengths - 30 catheters per box, each catheter is packaged in an individual
Recalled April 11, 2018 · FDA recall Z-1309-2018 · C.R. Bard
Hazard
Several instances of a catheter caught in the sterile barrier seal and in some instances cut catheters were observed. · FDA Class II
Units
10,949,013 units in total
Sold at
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
Description
Several instances of a catheter caught in the sterile barrier seal and in some instances cut catheters were observed.
Product
Personal Intermittent Catheters- 16" and 10" lengths - 30 catheters per box, each catheter is packaged in an individual pouch, Item Numbers: 50612, 50614, 50616, 50618, 52306, 52308, 52310, 52606, 52606G, 52608, 52608G, 52610, 52610G, 53314, 53320, 53514G, 53610, 53610G, 53612G, 53614G, 53616G, 53618G, 62308, 62310, 62606P, 602608, 62608P, 62610, 62610P, 63310, 63316, 63610, 63610M, 63612, 63612M, 63614, 63614M, 63616, 63616M, 63618, 71410, 72608, 72610, 73612, 73614, 73616 Product Usage Intermittent catheters are intended for urinary bladder drainage in patients requiring catheterization for management of incontinence, voiding dysfunction, and surgical procedures.
Manufacturer(s)
C.R. Bard, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →