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WECK Hemoclip¿ Traditional Medium Tantalum Ligating Clips. Weck Ligating Clips are intended fo...

FDA Recall #Z-0826-2015 — Class II — December 3, 2014

Recall #Z-0826-2015 Date: December 3, 2014 Classification: Class II Status: Terminated

Product Description

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.

Reason for Recall

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

Recalling Firm

Teleflex Medical — Durham, NC

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

3180 units

Distribution

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.

Code Information

Product Code: 523300, Lot number: 01B1400034

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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