Recall Z-0812-2016— C.R. Bard, Inc.
Class III · Terminated
Class III FDA medical device recall by C.R. Bard, Inc., initiated 2016-01-04, terminated 2017-06-06. FDA's recall record names no specific 510(k) clearance for this event. Product: REF 0038460 Toomey Syringe 70cc Syringe with Catheter Tip and Luer Tip Adapters, Single Use, Rx Only, Latex Free, 50 units. Product Usage: Product is intended for Resectoscope irrigation, catheter irrigation and Foley catheter inflation.. Reason: Report by a customer of an open package seal..
- Recalling firm
- C.R. Bard, Inc.
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2016-01-04
- Terminated
- 2017-06-06
- Firm location
- Covington, GA, United States
Product description
REF 0038460 Toomey Syringe 70cc Syringe with Catheter Tip and Luer Tip Adapters, Single Use, Rx Only, Latex Free, 50 units. Product Usage: Product is intended for Resectoscope irrigation, catheter irrigation and Foley catheter inflation.
Reason for recall
Report by a customer of an open package seal.
Data sourced from openFDA. This site is unofficial and independent of the FDA.