| Class 3 Device Recall BARD Toomey Irrigation Syringe 70cc | |
Date Initiated by Firm | January 04, 2016 |
Date Posted | February 16, 2016 |
Recall Status1 |
Terminated 3 on June 06, 2017 |
Recall Number | Z-0812-2016 |
Recall Event ID |
72977 |
Product Classification |
Syringe, irrigating (non dental) - Product Code KYZ
|
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. |
Code Information |
Lot Number NGZE1190 |
Recalling Firm/ Manufacturer |
C.R. Bard, Inc. 8195 Industrial Blvd NE Covington GA 30014-1497
|
For Additional Information Contact | Michael Wolfe 770-784-6220 |
Manufacturer Reason for Recall | Report by a customer of an open package seal. |
FDA Determined Cause 2 | Packaging process control |
Action | BMD sent an Urgent Medical Product Recall letter to each of the customers via FedEx with proof of delivery notice. The leter identified the affected product, problem and actions to be taken. All consignees were instructed to carry out the recall to the user level. The letter included a Recall and Effectiveness Check Form which was to be returned to Bard. |
Quantity in Commerce | 15,400 units |
Distribution | US Nationwide Distribution - in the states of: AL, AZ, CA, CO, FL, GA, IL, IN, IA, KS, KY, LA, MD, MI, MS, MO, NE, NV, NJ, NM, NY, NC, OH, OK, PA, SC, TN, TX, VA, WA, WV, and Puerto Rico |
Total Product Life Cycle | TPLC Device Report |
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
|
|
|