Device product
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
Z-0075-2018
Product summary
- Firm
- Terumo BCT, Inc.
- Event
- Event 78309
- Status
- Terminated
- Classification
- Class II
- Quantity
- 525 kits
- Official record key
device-enforcement:Z-0075-2018
Official wording
Reason: Certain lots of the Harvest Graft Delivery System GDP-10 Procedure Packs may have a lack of a seal on the inner pouch.
Code information: UDI Case 35020583514493, Each 05020583514492 Batch/Number: 04A9925, Exp. 01MAR2018; 05A9928, Exp. 01MAY2019; 06A9948, Exp. 01JUN2019; 06A9978, Exp. 01JUN2019; 08A9950, Exp. 01AUG2019
Distribution pattern: Nationwide Distribution including CA, CO, GA, LA, NJ, NV, NY, OR, PA, TX, and UT.
Derived failure modes
-
Unknown
Certain lots of the Harvest Graft Delivery System GDP-10 Procedure Packs may have a lack of a seal on the inner pouch.