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High RiskFDAfda-Z-1560-2014OTHER

Deknatel Teleflex Medical Stainless Steel 2 (metric 5) Monofilament Stainless Steel Suture, Nonabsorbable Surgical Suture, U.S.P. Used...

Units Affected
32,271
Recall Date
March 11, 2014
Issuing Agency
Hazard
Other

FDA Recall Notice

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1560-2014.

Product does not meet minimum needle attachment strength requirements; thus, the needle can become detached from the suture during use.

Corrective Action (per FDA)

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1560-2014.

Recall terminated by FDA.

✅ What you should do

  1. Stop using the product if you own it.
  2. Check the model number, lot code, or sell-by date against the recall notice above.
  3. Contact Teleflex Medical or the retailer where you bought it for a refund, replacement, or repair.
  4. For the most current official instructions, visit the FDA recall page.
  5. If you've been hurt by this product, report the incident to FDA.

Consumer Contact (per FDA)

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1560-2014.

Teleflex Medical

FDA

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Teleflex Medical Recall FAQ

Teleflex Medical is the subject of a medical implants safety report: Deknatel Teleflex Medical Stainless Steel 2 (metric 5) Monofilament Stainless Steel Suture, Nonabsorbable Surgical Suture, U.S.P. Used.... The notice was published on March 11, 2014 by the U.S. Food and Drug Administration (FDA). Approximately 32,271 units are potentially affected.