Recall Z-1534-2018 ยท FMF Syringe, Piston
Ethicon, Inc.
Evicel Accessory Device - 45 cm Flexible Tip (SET OF 3), Product Code EVT45. Accessory Tips for use only with EVICEL Fibrin Sealant (Human) Application Device.
| Date | Mar 7, 2018 |
| Status | Terminated |
| Reason | Products labeled for distribution outside the United States may have been distributed to customers in the United States. |
| Root cause | Other |
| Action | Letters distributed on 3/7/18 to hospitals instructed them to: 1. Examine your inventory immediately to determine if you have the product lot subject to this recall (removal) on hand and quarantine such product(s). 2. Remove the product lot subject to this recall (removal) and communicate the issue to all relevant operating room or materials management personnel, or anyone else in your facility who needs to be informed. If any of the devices subject to this recall (removal) have been forwarded to another facility, please contact that facility to arrange return. 3. Complete the Business Reply |
| Quantity | 738 devices (246 boxes of 3) |
| Distribution | The device was distributed to the following states: AK, AL, AR, AZ, CA, CO, FL, GA, IA, IL MD, MI, MN, MO, NC, ND, NJ, NV, NY, OH, PA, TN, TX, WA, WI, and WV. The device was also distributed to Puerto Rico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K070575 | EVICEL APPLICATION DEVICE Omrix Biopharmaceuticals , Ltd., May 29, 2007 |