Recalls / —

—#79684

Product

Pilling(R) Coronary Scissors, 60Deg 7", Catalog numbers: 352166, Teleflex Medical, Research Triangle Park, NC 27709

FDA product code

LRW — Scissors, General, Surgical

Device class

Class 1

Medical specialty

General, Plastic Surgery

Affected lot / code info

Date Codes: RR8, SS8, TT8, UU8, VV8, WW8, XX8, and MM9.

Why it was recalled

The product has a rough square finish instead of a smooth rounded finish which can cause damage to arteries.

Root cause (FDA determination)

Process control

Action the firm took

Consignees were notified by an Urgent Medical Device Recall letter, dated 03/03/2009, via UPS Next Day. Hospitals were instructed to immediately discontinue use of the products, inspect the scissors for the date codes and to return the product to Teleflex Medical for replacement. Distributors were instructed to forward the letter to their consignees to retrieve relevant product from those locations. A Recall Acknowledgement Form was attached to be completed and faxed back to Teleflex Medical. A second mailing to non-responding customers on the consignee list will be made approximately four to six weeks after the first mailing. A third mailing to non-responding customers on the consignee list will be made approximately four to six weeks after the second mailing or they may be contacted by phone, e-mail or fax. A record of these contacts will be maintained. Affected product retrieved by Teleflex Medical will be destroyed and replacement product provided to the consignee. Records of destruction will be maintained.

Recalling firm

Firm

Teleflex Medical

Address

4024 Stirrup Creek Dr, Durham, North Carolina 27703-9000

Distribution

Distribution pattern

Worldwide Distribution -- USA including states of AL, AZ, CA, CO, DC, DE, FL, IA, IN, KS, MA, MD, MI, MO, MS, NH, NJ, NY, NV, OH, OK, OR, PA, RI, TN, TX, UT, and WA, and countries of Australia, Canada, France, Germany, India, Japan, and Singapore.

Timeline

Recall initiated

2009-03-03

Posted by FDA

2009-04-09

Terminated

2011-03-31

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #79684. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.