Recall Z-1308-2018— 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: Magic 3 Intermittent Catheters- 12 Male - 30 catheters per box, each catheter is packaged in an individual pouch. Urinary catheter.. 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
Magic 3 Intermittent Catheters- 12 Male - 30 catheters per box, each catheter is packaged in an individual pouch. Urinary catheter.
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.