Pilling Center-Action Forceps with Insulated Shafts- Serrated Grasping Jaws, Catalog Number: 505015, Non...
Telefelx Medical began a recall of Pilling Center-Action Forceps with Insulated Shafts- Serrated Grasping Jaws, Catalog Number: 505015, Non Sterile, Rx Only, (ALLIG GRASPING FCPS 30 CM INSUL)... 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-0266-2008
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Teleflex Medical
- Product
- Pilling Center-Action Forceps with Insulated Shafts- Serrated Grasping Jaws, Catalog Number: 505015, Non Sterile, Rx Only, (ALLIG GRASPING FCPS 30 CM INSUL), 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
- 73
- 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, XX5, NN6, RR6, TT6, XX6, MM7, NN7, OO7, QQ7 and SS7
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