FDA-Device2014-04-30Class II

Monodek Violet Synthetic Absorbable Surgical Sutures, MF 0 TC43/HR26 48

Teleflex Medical
Hazard

Product does not meet minimum knot tensile strength requirements.

Sold states
Worldwide Distribution -- USA, including the state of MA, and the country of Germany
Affected count
3,072 ea.
Manufactured in
2917 Weck Dr., N/A, Research Triangle Park, NC, United States
Products
Monodek Violet Synthetic Absorbable Surgical Sutures, MF 0 TC43/HR26 48

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1509-2014

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