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Terminated

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

FDA Recall Z-0268-2008 · Posted 2007-11-29

Recalling FirmTelefelx Medical
Recall StatusTerminated
Product CodeHTD
Date Initiated2007-10-31
Date Terminated2009-08-31
Product Quantity113

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.

Firm 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.

Root Cause

Process control

Distribution Pattern

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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