Recall Z-1307-2018— C.R. Bard, Inc.
Class II · Terminated
Class II FDA medical device recall by C.R. Bard, Inc., initiated 2017-09-14, terminated 2019-11-05. It names 2 FDA 510(k) clearances: K122785, K000723. 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.. Reason: Several instances of a catheter caught in the sterile barrier seal and in some instances cut catheters were observed..
- Recalling firm
- C.R. Bard, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-09-14
- Terminated
- 2019-11-05
- Firm location
- Covington, GA, United States
510(k) clearances named in this recall
2 on FDA's record- K122785 — HYDROSIL; MAGIC; PERSONAL CATHETER
- K000723 — HYDROPHILIC SILICONE FOLEY CATHETER AND PERSONAL CATHETER (HYDROPHILIC AND NON-HYDROPHILIC)
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.