HydroSil Gripper Intermittent Catheters- 10" lengths - 30 catheters per box, each catheter is packaged in an individual
FDA device recall Z-1307-2018 · posted 2018-04-04 · Terminated
Recall details
- Recalling firm
- C.R. Bard, Inc.
- Reason for recall
- Several instances of a catheter caught in the sterile barrier seal and in some instances cut catheters were observed.
- Action taken
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- EZD
- Quantity 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
- Date initiated
- 2017-09-14
- Date posted
- 2018-04-04
- Date terminated
- 2019-11-05
- Location
- Covington, GA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HYDROSIL; MAGIC; PERSONAL CATHETER (K122785) | Rochester Medical Corp. | 2013-05-14 |
| HYDROPHILIC SILICONE FOLEY CATHETER AND PERSONAL CATHETER (HYDROPHILIC AND NON-HYDROPHILIC) (K000723) | Rochester Medical Corp. | 2000-05-19 |