FDA Recall
Terminated
TLC Self Retaining Retractor System Contents 1-RETRACTOR FRAME 6-ELASTIC STAYS STERILE EO Rx ONLY. Indicated for use in the retraction of soft tissue away from the operative surface.
Recall: Z-0684-2016
·
Initiated November 25, 2015
Recall
- Recall Number
- Z-0684-2016
- Event Number
- 72836
- Firm
- Abeon Medical Corporation
- FEI Number
- 3008657512
- Product Code
- FFO
- Status
- Terminated
- Root Cause
- Packaging
- Initiated
- November 25, 2015
- Terminated
- October 27, 2016
- Address
- 8000 Katherine Blvd, Brecksville, OH, 44141-4202
Description
TLC Self Retaining Retractor System Contents 1-RETRACTOR FRAME 6-ELASTIC STAYS STERILE EO Rx ONLY. Indicated for use in the retraction of soft tissue away from the operative surface.
Reason
The firm was notified by some of their customers that some of the sealed pouches contain tears compromising the sterility of the product.
Action
On 12/17/2015 the firm sent Recall Notification Letters to their customers. The letter identified the product, problem, and actions to be taken by the customer.
Distribution
Worldwide Distribution-US (nationwide) including the states of AL, AR, AZ, CA, CT,FL, GA, IA, IN, KS, KY, MA, MD, MI, MN, NC, NH, NJ, OH, SC, TN, TX, UT, VA & WI., and the countries of Austria, Germany, Italy, Japan, Spain, Sweden & Switzerland.
Quantity
2,570 units