FDA Medical Device Recalls (openFDA)
Teleflex Medical: Fixt Suture Bonded Plus Violet Braided Polyglycolic Acid Coated Suture, Synthetic Absorbable Surgical Suture, Sterile, Rx Only, Teleflex Medical. Indicated for use in soft tissue approximation.
- Recall number
- Z-1558-2014
- Recalling firm
- Teleflex Medical
- Product
- Fixt Suture Bonded Plus Violet Braided Polyglycolic Acid Coated Suture, Synthetic Absorbable Surgical Suture, Sterile, Rx Only, Teleflex Medical. Indicated for use in soft tissue approximation.
- Status
- Terminated
- Initiated
- 2014-03-11
- Posted
- 2014-05-07
- Terminated
- 2017-08-14
- Reason
- Product does not meet minimum needle attachment strength requirements; thus, the needle can become detached from the suture during use.
- Root cause
- Employee error
- Action
- Urgent Medical Device Recall Notification letters were issued on March 11, 2014 to consignees. The letter requested that customers discontinue use and quarantine any product on hand. The attached Recall Acknowledgment Form should be completed and returned to Teleflex regardless of whether affected product is on hand or not. Once received a customer service representative will contact customers with instructions on how to return the affected product. Questions should be directed to Customer Service at 1-866-246-6990.
- Quantity
- 32,271 ea.
- Distribution
- Worldwide Distribution -- USA, including the states of AL, CA, FL, GA, IL, IN, KS, LA, ME, MA, MI, MN, MS, MO, NV, NJ, NM, NY, OH, PA, RI, SC, TN, TX, UT, VA, WV, and WI; and countries of Canada, Germany, and Ireland.
- Lot, serial or model codes
- Product Code BON100 - Lot 02H1302839, 02J1101705, 02D1101137, 02F1103013, Product Code EP4049N - Lot 02A1003137
- 510(k) numbers
- ["K930738"]
- PMA numbers
- not on file
- Product code
- GAM
- 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