Recall Z-0268-2008
Telefelx Medical · initiated October 31, 2007
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
Codes / lots: Date Codes: UU5, MM6, OO7, RR7 and SS7
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: 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.
Details
- Recall number
- Z-0268-2008
- Initiated
- October 31, 2007
- Posted by FDA
- November 29, 2007
- Terminated
- August 31, 2009
- Product code
- HTD – Forceps
- Quantity
- 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.
- Recalling firm
- Telefelx Medical, Durham, NC
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0266-2008 | Pilling Center-Action Forceps with Insulated Shafts- Serrated Grasping Jaws, Catalog…The specified insulation is not present on the shaft of the devices, leaving a risk of arcing and/or damage… | 10/31/2007Terminated |
| Z-0267-2008 | Pilling Center-Action Forceps with Insulated Shafts- Elongated Cup Biopsy Jaws, Catalog…The specified insulation is not present on the shaft of the devices, leaving a risk of arcing and/or damage… | 10/31/2007Terminated |