Recall Z-1559-2014— Teleflex Medical
Class II · Terminated
Class II FDA medical device recall by Teleflex Medical, initiated 2014-03-11, terminated 2017-08-14. It names 2 FDA 510(k) clearances: K063778, K930738. Product: Bard Fixt Suture Braided Polyester, Rx Only, Teleflex Medical, Research Triangle Park, NC USA Assembled in Mexico. Indicated for use in soft tissue approximation.. Reason: Product does not meet minimum needle attachment strength requirements; thus, the needle can become detached from the suture during use..
- Recalling firm
- Teleflex Medical
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-03-11
- Terminated
- 2017-08-14
- Firm location
- Durham, NC, United States
510(k) clearances named in this recall
2 on FDA's record- K063778 — FORCE FIBER POLYETHYLENE NONABSORBABLE SUTURE
- K930738 — SURGICAL SUTURES, PGL, GUT, DEKLENE, OPTHAMEND ETC
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
Bard Fixt Suture Braided Polyester, Rx Only, Teleflex Medical, Research Triangle Park, NC USA Assembled in Mexico. Indicated for use in soft tissue approximation.
Reason for recall
Product does not meet minimum needle attachment strength requirements; thus, the needle can become detached from the suture during use.
Data sourced from openFDA. This site is unofficial and independent of the FDA.