Z-1307-2018 Class II Terminated
FDA device recall Z-1307-2018 was initiated by C.R. Bard, Inc. on September 14, 2017 and is designated Class II. Reason for recall: Several instances of a catheter caught in the sterile barrier seal and in some instances cut catheters were observed. The recall status is terminated (terminated November 5, 2019). Affected quantity: 44640.0 units.
Recall Details
- Product Type
- Devices
- Report Date
- April 11, 2018
- Initiation Date
- September 14, 2017
- Termination Date
- November 5, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 44640.0 units
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.
Reason for Recall
Several instances of a catheter caught in the sterile barrier seal and in some instances cut catheters were observed.
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
Code Information
Item 50610 Lots #'s: JUBT0404, JUBP0700, JUBR2498, JUBS1289