Monodek Violet Synthetic Absorbable Surgical Sutures, MF 0 TC43/HR26 48
This recall has been terminated (originally issued April 25, 2014).
- Company
- Teleflex Medical
- Recall Initiated
- March 11, 2014
- Posted
- April 25, 2014
- Terminated
- September 25, 2017
- Recall Number
- Z-1509-2014
- Quantity
- 3,072 ea.
- Firm Location
- Research Triangle Park, NC
- Official Source
- View on FDA website ↗
Reason for Recall
Product does not meet minimum knot tensile strength requirements.
Distribution
Worldwide Distribution -- USA, including the state of MA, and the country of Germany
Lot / Code Info
Product Code: 833-137, Batch: 02H1103434, 02H1200349, and 02K1201354.
Root Cause
Under Investigation by firm
Action Taken
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.