Reported Nov 15, 2017 · Terminated
HARVEST TERUMOBCT, GCP-10 Graft Delivery Pack, REF 51449, Rx Only, STERILE EO Harvest Graph Delivery System is a…
Terumo BCT, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Terumo BCT, Inc. · 10811 W Collins Ave · Lakewood, CO · 80215-4440
Is this the product you have?
- 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
- Lot codes and dates
- UDI Case 35020583514493
- Each 05020583514492 Batch/Number
04A9925Exp. 01MAR201805A9928Exp. 01MAY201906A9948Exp. 01JUN201906A9978Exp. 01JUN201908A9950Exp. 01AUG2019
- Amount recalled
- 525 kits
Where it was sold
Why it was recalled
Certain lots of the Harvest Graft Delivery System GDP-10 Procedure Packs may have a lack of a seal on the inner pouch.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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