Recall Z-1738-2016 ยท GDY Gauze/Sponge, Internal, X-Ray Detectable
American Surgical Company
American Surgical Ultracot 5 mm x 13 mm (Glassine) Ref Number: 23-02G Product Usage: Neurosurgical and Nonneurosurgical Sponges
| Date | Mar 31, 2016 |
| Status | Terminated |
| Reason | Product packaging defective compromising sterility |
| Root cause | Packaging process control |
| Action | American Surgical issued an Urgent Recall and Field Safety Notice letter dated March 31, 2016 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were provided instruction to address affected devices in their inventory. They should address this by either selecting Action A or B: Action A: Users should perform a check of the device before use and, as stated in the IFU, patties should not be used if in an open or damaged pouch. For the affected lots, special attention should be given to lower portion of the pouch where the Tyvek and |
| Quantity | 15 boxes |
| Distribution | Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K854714 | X-RAY DETECTABLE COTTON BALLS American Silk Sutures, Inc., Dec 17, 1985 |