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U.S. Department of Health and Human Services

Class 3 Device Recall BARD Toomey Irrigation Syringe 70cc

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  Class 3 Device Recall BARD Toomey Irrigation Syringe 70cc see related information
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.
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