Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0267-2008

Pilling Center-Action Forceps with Insulated Shafts- Elongated Cup Biopsy Jaws, Catalog Number: 505039, Non...

Teleflex Medical / initiated 2007-10-31 / Terminated / root cause: manufacturing process

Telefelx Medical began a recall of Pilling Center-Action Forceps with Insulated Shafts- Elongated Cup Biopsy Jaws, Catalog Number: 505039, Non Sterile, Rx Only, (30 CM), Manufactured for... on . The reason FDA records is "The specified insulation is not present on the shaft of the devices, leaving a risk of arcing and/or damage to surrounding tissue". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-0267-2008
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Teleflex Medical
Product
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
Product code
HTD Forceps
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.
Root cause tag
manufacturing process
FDA root cause
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
49
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.
Product codes and lots
Date Codes: WW5, MM6 and SS7