Recall Z-1497-2014— Teleflex Medical

Class II · Terminated

Class II FDA medical device recall by Teleflex Medical, initiated 2014-03-11, terminated 2015-12-17. It names one FDA 510(k) clearance: K930738. Product: 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.. Reason: The products are being recalled because they did not meet minimum diameter requirements..

Recalling firm
Teleflex Medical
Classification
Class II
Status
Terminated
Initiated
2014-03-11
Terminated
2015-12-17
Firm location
Research Triangle Park, NC, United States

510(k) clearances named in this recall

1 on FDA's record

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

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.

Reason for recall

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

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