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U.S. Department of Health and Human Services

Class 2 Device Recall Modular Verres Body/Obturator

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  Class 2 Device Recall Modular Verres Body/Obturator see related information
Date Initiated by Firm January 08, 2015
Date Posted March 16, 2016
Recall Status1 Terminated 3 on April 14, 2017
Recall Number Z-1178-2016
Recall Event ID 73267
Product Classification Needle, aspiration and injection, reusable - Product Code GDM
Product Pilling Modular Verres Body/Obturator, Product Code 140880
Code Information Lot K3
Recalling Firm/
Manufacturer		 Teleflex Medical
2917 Weck Dr
Research Triangle Park NC 27709-0186
For Additional Information Contact Tara Torres-Heckman
610-378-0131
Manufacturer Reason
for Recall		 Packaging error in which customers who ordered product code 140880 (Verres cannula for use with a separately available needle tip) were incorrectly provided with product code 140878 (Verres cannula with integral needle tip).
FDA Determined
Cause 2		 Packaging process control
Action Teleflex sent an Medical Device Advisory Notification letter dated January 8, 2016, to all affected customers notifying them of the packaging error. Our records indicate that you have received products that are subject to this notification. Teleflex Medical is committed to providing high quality, safe and effective products. We sincerely apologize for any inconvenience this action may cause your operations. If you have any other questions, feel free to contact your local sales representative or Customer Service at recalls@teleflex.com or 1-866-246-6990.
Quantity in Commerce 8
Distribution US Distribution to the state of : UT
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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