Recall Z-1609-2016 ยท GAD Retractor
Applied Medical Technology Inc
TLC Self-Retaining Retractor Frames SINGLE USE ONLY Rx ONLY (USA) STERILE EO Do Not Resterilize. Product Usage: Indicated to aid in tissue retraction during a surgical procedure.
| Date | Feb 17, 2016 |
| Status | Terminated |
| Reason | The firm received a complaint of an open pouch which breaches the sterilization validation. |
| Root cause | Packaging |
| 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. |
| Quantity | 3,754 Units |
| 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 King |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.