FDA-Device2014-04-30Class II

Monofilament and Multifilament Non-absorbable Steel Suture; Product Codes: 0520197-2, 29-727, 29-7270M4, 29-7281M4, E29-5553M4, E29-7270M4, E29-7272M4, E29-727A, EP4013P, EP4110N, X-2235, X29-7271M2, X-5667M8 and X-6730M5.

Teleflex Medical
Hazard

The products are being recalled because they did not meet minimum diameter requirements.

Sold states
Worldwide Distribution - CA, CO, FL, IN, KY, MA, NM, PA, Canada, Ireland and Germany.
Affected count
3,816 ea
Manufactured in
2917 Weck Dr., N/A, Research Triangle Park, NC, United States
Products
Monofilament and Multifilament Non-absorbable Steel Suture; Product Codes: 0520197-2, 29-727, 29-7270M4, 29-7281M4, E29-5553M4, E29-7270M4, E29-7272M4, E29-727A, EP4013P, EP4110N, X-2235, X29-7271M2, X-5667M8 and X-6730M5.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1497-2014

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