FDA Medical Device Recalls (openFDA)
Teleflex Medical: Pilling(R) Coronary Scissors, 25Deg 7", Catalog numbers: 352164, Teleflex Medical, Research Triangle Park, NC 27709
- Recall number
- Z-1175-2009
- Recalling firm
- Teleflex Medical
- Product
- Pilling(R) Coronary Scissors, 25Deg 7", Catalog numbers: 352164, Teleflex Medical, Research Triangle Park, NC 27709
- Status
- Terminated
- Initiated
- 2009-03-03
- Posted
- 2009-04-09
- Terminated
- 2011-03-31
- Reason
- The product has a rough square finish instead of a smooth rounded finish which can cause damage to arteries.
- 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
- 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.
- Lot, serial or model codes
- Date Codes: RR8, SS8, TT8, UU8, VV8, WW8, XX8, and MM9.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LRW
- Firm FEI
- 3005747797
- Firm city
- Durham
- Firm state
- NC
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28