FDA Medical Device Recalls (openFDA)
Teleflex Medical: Monodek Violet Synthetic Absorbable Surgical Sutures, MF 0 TC43/HR26 48
- Recall number
- Z-1509-2014
- Recalling firm
- Teleflex Medical
- Product
- Monodek Violet Synthetic Absorbable Surgical Sutures, MF 0 TC43/HR26 48
- Status
- Terminated
- Initiated
- 2014-03-11
- Posted
- 2014-04-25
- Terminated
- 2017-09-25
- Reason
- Product does not meet minimum knot tensile strength requirements.
- Root cause
- Under Investigation by firm
- Action
- Consignees were notified by an Urgent Medical Device Recall Notification letter, dated 3/11/2014. The letter identified the affected product and the reason for recall. Customers were instructed to immediately discontinue use of and quarantine any affected product in stock. The affected product is to be returned; and the Recall Acknowledgement Form should be completed and faxed to the number provided regardless of whether customers have affected product in stock. Questions should be directed to a local sales rep or Customer Service at 1-866-246-6990.
- Quantity
- 3,072 ea.
- Distribution
- Worldwide Distribution -- USA, including the state of MA, and the country of Germany
- Lot, serial or model codes
- Product Code: 833-137, Batch: 02H1103434, 02H1200349, and 02K1201354.
- 510(k) numbers
- ["K030212"]
- PMA numbers
- not on file
- Product code
- NEW
- Firm FEI
- 3005747797
- Firm city
- Research Triangle Park
- 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
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
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