—#131956

Product

WECK Hemoclip Traditional Medium Tantalum Ligating Clips. Weck Ligating Clips are intended for use in procedures involving vessels or anatomic structures for which the surgeon determines ligating clips are the best choice.

FDA product code: FZP — Clip, Implantable
Device class: Class 2
Medical specialty: General, Plastic Surgery
510(k) numbers: K800079
Affected lot / code info: Product Code: 523300, Lot number: 01B1400034

Why it was recalled

The manufacturing dates and expiration dates were transposed on the Tyvek label.

Root cause (FDA determination)

Labeling Change Control

Action the firm took

Consignees were notified by letter on 12/03/2014.

Recalling firm

Firm: Teleflex Medical
Address: 4024 Stirrup Creek Dr, Durham, North Carolina 27703-9000

Distribution

Distribution pattern: US (nationwide) including the states of AL, CA, FL, DE, IA, IL, IN, KY, MA, MN, NC, NE, NJ, NY, NV, OH, OK, PA, TX, VA, VT, and WA.

Timeline

Recall initiated: 2014-12-03
Posted by FDA: 2014-12-17
Terminated: 2017-11-24
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #131956. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.