Recall Z-2191-2015— American Catheter Corp
Class II · Terminated
Class II FDA medical device recall by American Catheter Corp, initiated 2015-03-17, terminated 2016-12-14. FDA's recall record names no specific 510(k) clearance for this event. Product: American Catheter / Cholangiogram Catheter 9100 Series.. Reason: Catheters were not sealed before sterilization. and was not detected through subsequent acceptance activities, product release and distribution..
- Recalling firm
- American Catheter Corp
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-03-17
- Terminated
- 2016-12-14
- Firm location
- Ocala, FL, United States
Product description
American Catheter / Cholangiogram Catheter 9100 Series.
Reason for recall
Catheters were not sealed before sterilization. and was not detected through subsequent acceptance activities, product release and distribution.
Data sourced from openFDA. This site is unofficial and independent of the FDA.