Beall(R) Circumflex Artery Scissors, Catalog numbers: 352169, Teleflex Medical, Research Triangle Park, NC 27709

FDA device recall Z-1180-2009 · posted 2009-04-09 · Terminated

Recall details

Recalling firm

Teleflex Medical

Reason for recall

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

Action taken

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.

Root cause

Process control

Status

Terminated

Product code

LRW

Quantity affected

497 of all units

Distribution

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

Date initiated

2009-03-03

Date posted

2009-04-09

Date terminated

2011-03-31

Location

Durham, NC