Recall Z-2300-2012 ยท FTN Plastic Surgery And Accessories Kit
SRI Surgical
Various SRI Surgical Disposable Accessory Packs. SRI's Disposable Accessory Packs (also commonly known as convenience kits and custom procedure trays) are an assembly of medical devices packaged together according to the customer specifications, which are then wrapped in a sterilization wrap and sterilized. This allows the customer to open one package for a surgical procedure instead of many indi
| Date | Aug 29, 2012 (initiated Jul 16, 2008) |
| Status | Terminated |
| Reason | Distribution of a product that did not meet specifications. (labeling error) |
| Root cause | Component change control |
| Action | SRI sent a "MEDICAL DEVICE CORRECTION" letter dated July 16, 2008 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. Contact the firm at 813-891-9550 ext. 3124 for questions regarding this recall. |
| Quantity | 802,135 |
| Distribution | Nationwide Distribution-including the states of CA, FL, GA, KY, MD, MI, NC, NJ, OK, PA, SC, TN, TX, and UT. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.