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Terminated

TLC Self Retaining Retractor System Contents 1-RETRACTOR FRAME 6-ELASTIC STAYS STERILE EO Rx ONLY Product Usage: Indicated to aid in tissue retraction during a surgical procedure.

FDA Recall Z-1608-2016 · Posted None

Recalling FirmApplied Medical Technology Inc
Recall StatusTerminated
Product CodeGAD
Date Initiated2016-02-17
Date Terminated2016-10-27
Product Quantity5,334 units

Reason for Recall

The firm received a complaint of an open pouch which breaches the sterilization validation.

Firm Action

AMT sent an Urgent Medical Device Recall letter dated February 17, 2016 to their customers. The letter identified the affected product, problem and actions to be taken. For questions contact Customer Service at 440-717-4000.

Root Cause

Packaging

Distribution Pattern

Product was shipped to the following states: AL, AR, AZ, CA, CT, FL, GA, IA, IN, KS, KY, MA, MD, MI, MN, MO, NC, NE, NH, NJ, OH, PA, SC, TN,TX, UT, VA & WI. Product was also shipped to the following countries: Austria, Denmark, Germany, Italy, Japan, Norway, Spain, Sweden, Switzerland & United Kingdom.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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