Pilling Center-Action Forceps with Insulated Shafts- Elongated Cup Biopsy Jaws, Catalog Number: 505039, Non Sterile, Rx Only, (30 CM), Manufactured for: Teleflex Medical, Research Triangle Park, NC 27709 USA
This recall has been terminated (originally issued November 29, 2007).
- Company
- Telefelx Medical
- Recall Initiated
- October 31, 2007
- Posted
- November 29, 2007
- Terminated
- August 31, 2009
- Recall Number
- Z-0267-2008
- Quantity
- 49
- Firm Location
- Durham, NC
- Official Source
- View on FDA website ↗
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.
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.
Lot / Code Info
Date Codes: WW5, MM6 and SS7
Root Cause
Process control
Action Taken
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.