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.
- Company
- Applied Medical Technology Inc
- Recall Initiated
- February 17, 2016
- Terminated
- October 27, 2016
- Recall Number
- Z-1608-2016
- Quantity
- 5,334 units
- Firm Location
- Brecksville, OH
Reason for Recall
The firm received a complaint of an open pouch which breaches the sterilization validation.
Distribution
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.
Lot / Code Info
Part #: M0068201750; Part #: M0068201761;
Root Cause
Packaging
Action Taken
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.
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