FDAFDA · Food and drugs·Recall number Z-0075-2018
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
Published November 15, 2017 · Recall initiated: October 20, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Certain lots of the Harvest Graft Delivery System GDP-10 Procedure Packs may have a lack of a seal on the inner pouch.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Terumo BCT, Inc.
- Distributor
- Nationwide Distribution including CA, CO, GA, LA, NJ, NV, NY, OR, PA, TX, and UT.
- Lot
- UDI Case 35020583514493, Each 05020583514492 Batch/Number: 04A9925, Exp. 01MAR2018; 05A9928, Exp. 01MAY2019; 06A9948, Exp. 01JUN2019; 06A9978, Exp. 01JUN2019; 08A9950, Exp. 01AUG2019
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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