PlainRecalls
FDA Devices Moderate Class II Terminated

Dekna-lok, 1 x 17.78 cm, Violet Braided Polyglycolic Acid Coated Suture, Synthetic Absorbable Surgical Suture USP, Rx Only, Sterile. Teleflex Product Code: 200101-01.

Reported: May 7, 2014 Initiated: March 11, 2014 #Z-1535-2014

Product Description

Dekna-lok, 1 x 17.78 cm, Violet Braided Polyglycolic Acid Coated Suture, Synthetic Absorbable Surgical Suture USP, Rx Only, Sterile. Teleflex Product Code: 200101-01.

Reason for Recall

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

Details

Recalling Firm
Teleflex Medical
Units Affected
7,380 ea (total)
Distribution
Worldwide Distribution - US Nationwide in the states of CA, CO, GA, LA, IL, MA, MI, MN, MO, NC, and in the countries of Ireland and Singapore.
Location
Research Triangle Park, NC

Frequently Asked Questions

What product was recalled?
Dekna-lok, 1 x 17.78 cm, Violet Braided Polyglycolic Acid Coated Suture, Synthetic Absorbable Surgical Suture USP, Rx Only, Sterile. Teleflex Product Code: 200101-01.. Recalled by Teleflex Medical. Units affected: 7,380 ea (total).
Why was this product recalled?
The product did not meet minimum and/or average minimum Teleflex resorption strength requirements.
Which agency issued this recall?
This recall was issued by the FDA Devices on May 7, 2014. Severity: Moderate. Recall number: Z-1535-2014.