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U.S. Department of Health and Human Services

Class 2 Device Recall Pilling CenterAction Forceps

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  Class 2 Device Recall Pilling CenterAction Forceps see related information
Date Initiated by Firm October 31, 2007
Date Posted November 29, 2007
Recall Status1 Terminated 3 on August 31, 2009
Recall Number Z-0268-2008
Recall Event ID 45515
Product Classification Forceps - Product Code HTD
Product Pilling¿ Center-Action Forceps with Insulated Shafts- Circular Cup Biopsy Jaws, Catalog Number: 505045, Non Sterile, Rx Only, (30 CM), Manufactured for: Teleflex Medical, Research Triangle Park, NC 27709 USA
Code Information Date Codes: UU5, MM6, OO7, RR7 and SS7
Recalling Firm/
Manufacturer		 Telefelx Medical
2917 Weck Drive
Durham NC 27709
For Additional Information Contact Janis Wilson
919-443-4973
Manufacturer Reason
for Recall		 The specified insulation is not present on the shaft of the devices, leaving a risk of arcing and/or damage to surrounding tissue.
FDA Determined
Cause 2		 Process control
Action Consignees were notified by an Urgent Medical Device Recall letter on/about 11/1/2007. They were instructed to immediately cease use and distribution of the affected product and to return them to Teleflex Medical, Durham, NC. In addition, each were instructed to forward the letter if they had further distribution into institutional settings or to homecare patients and retrieve relevant product form those locations. An Acknowledgement & Stock Status Form was enclosed to be completed and faxed back to Teleflex Medical.
Quantity in Commerce 113
Distribution Worldwide: USA including states of AL, AR, AZ, CA, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NM, NY, NV, OH, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV, and countries of Canada, France New Zealand and Singapore.
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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