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

FDA device recall Z-0267-2008 · posted 2007-11-29 · Terminated

Recall details

Recalling firm

Telefelx Medical

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.

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.

Root cause

Process control

Status

Terminated

Product code

HTD

Quantity affected

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

Date initiated

2007-10-31

Date posted

2007-11-29

Date terminated

2009-08-31

Location

Durham, NC