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Recall Observatory FDA recall evidence

Device 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.

Z-0826-2015

December 03, 2014

Class II

Product summary

Firm
Teleflex Medical
Event
Event 69918
Status
Terminated
Classification
Class II
Quantity
3180 units
Official record key
device-enforcement:Z-0826-2015

Official wording

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

Code information: Product Code: 523300, Lot number: 01B1400034

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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