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.
Reported: April 11, 2018 Initiated: September 14, 2017 #Z-1307-2018
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.
Details
- Recalling Firm
- C.R. Bard, Inc.
- Units Affected
- 44640.0 units
- Distribution
- 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
- Location
- Covington, GA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by C.R. Bard, Inc.. Units affected: 44640.0 units.
Why was this product recalled? ▼
Several instances of a catheter caught in the sterile barrier seal and in some instances cut catheters were observed.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 11, 2018. Severity: Moderate. Recall number: Z-1307-2018.
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