Z-1175-2009

Pilling(R) Coronary Scissors, 25Deg 7", Catalog numbers: 352164, Teleflex Medical, Research Triangle Park, NC...

Name: Z-1175-2009 Pilling(R) Coronary Scissors, 25Deg 7", Catalog numbers: 352164, Teleflex Medical, Research Triangle Park, NC...
Creator: Teleflex Medical
Published: 2009-03-03
License: https://open.fda.gov/license/

Teleflex Medical / initiated 2009-03-03 / Terminated / root cause: manufacturing process

FDA source

Teleflex Medical began a recall of Pilling(R) Coronary Scissors, 25Deg 7", Catalog numbers: 352164, Teleflex Medical, Research Triangle Park, NC 27709 on 2009-03-03. The reason FDA records is "The product has a rough square finish instead of a smooth rounded finish which can cause damage to arteries". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1175-2009
Status: Terminated
Initiated: 2009-03-03
Posted: 2009-04-09
Terminated: 2011-03-31
Recalling firm: Teleflex Medical
Product: Pilling(R) Coronary Scissors, 25Deg 7", Catalog numbers: 352164, Teleflex Medical, Research Triangle Park, NC 27709
Product code: LRW Scissors, General, Surgical
Reason for recall: The product has a rough square finish instead of a smooth rounded finish which can cause damage to arteries.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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.
Quantity in commerce: 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, France, Germany, India, Japan, and Singapore.
Product codes and lots: Date Codes: RR8, SS8, TT8, UU8, VV8, WW8, XX8, and MM9.

Product code LRW

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)