Recall Z-1534-2014— Teleflex Medical

Name: FDA recall Z-1534-2014
Creator: U.S. Food and Drug Administration
Published: 2014-03-11

Class II · Terminated

Class II FDA medical device recall by Teleflex Medical, initiated 2014-03-11, terminated 2016-03-29. It names one FDA 510(k) clearance: K030212. Product: CAPIO, Monodeck, Violet Monofilament Polydioxanone Suture, 1 x 48 inches (122cm) Absorbable Surgical Suture, Rx Only, Teleflex Medical. Product Code: 833-137.. Reason: The product did not meet minimum and/or average minimum Teleflex resorption strength requirements..

Recalling firm: Teleflex Medical
Classification: Class II
Status: Terminated
Initiated: 2014-03-11
Terminated: 2016-03-29
Firm location: Research Triangle Park, NC, United States

510(k) clearances named in this recall

1 on FDA's record

K030212 — MONODEK SYNTHETIC ABSORBABLE SURGICAL SUTUREGenzyme Biosurgery·cleared 2003-03-27

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

CAPIO, Monodeck, Violet Monofilament Polydioxanone Suture, 1 x 48 inches (122cm) Absorbable Surgical Suture, Rx Only, Teleflex Medical. Product Code: 833-137.

Reason for recall

The product did not meet minimum and/or average minimum Teleflex resorption strength requirements.

Data sourced from openFDA. This site is unofficial and independent of the FDA.