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Recall Observatory FDA recall evidence

Device product

Horizon 24 Large Titanium Clips with Adhesive Backing, Ref 004204, Rx Only, Sterile. The metal ligating clips are intended for use in procedures involving vessels or anatomic structures for which the surgeon determines ligating clips are the best choice. An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable

Z-2327-2016

August 08, 2013

Class II

Product summary

Firm
Teleflex Medical
Event
Event 74669
Status
Terminated
Classification
Class II
Quantity
8,220 ea.
Official record key
device-enforcement:Z-2327-2016

Official wording

Reason: The manufacturing and expiration dates are not printed on the blister pack label.

Code information: Lot/Serial Number 01J1200435

Distribution pattern: USA Distribution to the states of :AL, AZ, CA, CT, FL, IL, KY, MD, MI, MN, NM, NY, NC, OR, PA, SC, TX, VA, WA, WI, and Internationally to Canada

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The manufacturing and expiration dates are not printed on the blister pack label.