Teleflex Medical: Medical Device Recall in 2014 - (Recall #: Z-1558-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

Fixt Suture Bonded Plus Violet Braided Polyglycolic Acid Coated Suture, Synthetic Absorbable Surgical Suture, Sterile, Rx Only, Teleflex Medical. Indicated for use in soft tissue approximation.

Product Classification:

Class II

Date Initiated: March 11, 2014

Date Posted: May 14, 2014

Recall Number: Z-1558-2014

Event ID: 67711

Reason for Recall:

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

Status: Terminated

Product Quantity: 32,271 ea.

Code Information:

Product Code BON100 - Lot 02H1302839, 02J1101705, 02D1101137, 02F1103013, Product Code EP4049N - Lot 02A1003137

Distribution Pattern:

Worldwide Distribution -- USA, including the states of AL, CA, FL, GA, IL, IN, KS, LA, ME, MA, MI, MN, MS, MO, NV, NJ, NM, NY, OH, PA, RI, SC, TN, TX, UT, VA, WV, and WI; and countries of Canada, Germany, and Ireland.

Voluntary or Mandated:

Voluntary: Firm initiated