Recalling Firm / Manufacturer

Teleflex Creek Dr

Product

Suture Diameter/Strength specification failure: Various Polydioxanone Absorbable Surgical Sutures-NDR, MDK VI MF 0 TC43/HR2648, Catalog #833-137, Monodek, MDK VI MF 2-0 FS-1 1N27, Catalog # M451V

Code Information

NDR, MDK VI MF 0 TC43/HR2648, Catalog #833-137, Lot #2503061, 2503063, 2761528, 2761529 2694983, 3152877, 3169994, 2395967, 3163970 & 3232258; Monodek, MDK VI MF 2-0 FS-1 1N27, Catalog # M451V, Lot #2360982 & 2381287.

Reason of Recall

The products may not meet their final specifications for suture diameter and/or strength which could lead to premature breakage.

Date Recall Initiated

June 06, 2007

Action

Consignees were notified by letter on/about 06/07/2007. They were advised to cease use, remove and quarantine all affected product immediately. Affected products are to be returned to Teleflex Medical. An Acknowledgement & Stock form was included to be completed and returned via fax to Teleflex Medical. Firm Initiated recall is ongoing.

Contact

AMHSCO
Riyadh
(01) 4621188

Source of Information

U.S FDA

SFDA Comments

SFDA urges all hospitals that have devices subjected to recall, to contact the company.