Recall Z-0075-2018 ยท FMF Syringe, Piston
Terumo BCT, Inc.
HARVEST TERUMOBCT, GCP-10 Graft Delivery Pack, REF 51449, Rx Only, STERILE EO Harvest Graph Delivery System is a disposable pack that takes the cell concentrate created while using the BMAC Procedure Packs and allows for hydration of bone graft material for application to the sites doctors deem necessary
| Date | Oct 20, 2017 |
| Status | Terminated |
| Reason | Certain lots of the Harvest Graft Delivery System GDP-10 Procedure Packs may have a lack of a seal on the inner pouch. |
| Root cause | Packaging |
| Action | Harvest Terumo sent a Voluntary Medical Device Product Recall letter dated October 20, 2017, to all affected customers. The letter stated the following: "ACTIONS REQUIRED FOR HEALTHCARE PROVIDERS AND DISTRIBUTORS 1. For product shelved in the original case (white box), or kit components, examine the outer label for catalog/lot numbers as shown in Figure A above. 2. Please return any unused affected product in your inventory. Please contact your local Terumo BCT Customer Support Center at 1.877.3.FYI.BCT (U.S. toll-free 1.877.339.4228) or +1.303.231.HELP (+1.303.231.4357), Terumo BCT Eu |
| Quantity | 525 kits |
| Distribution | Nationwide Distribution including CA, CO, GA, LA, NJ, NV, NY, OR, PA, TX, and UT. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K043261 | HARVEST GRAFT DELIVERY SYRINGE Harvest Technologies, Corp., Mar 11, 2005 |