FDAOctober 20, 2017device
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 n...
Official recall recorded by the U.S. Food & Drug Administration.
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
FDA enforcement status: Terminated
Brands named
terumo bctterumo
UPCs
3502058351449305020583514492
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDACDI OneView System BPM Probe: Cat. No. CDI753 - CDI OneView BPM Probe, Cat. No. CDI753TK - CDI OneView BPM Probe Trial Kit2025-05-28
- FDATerumo CDI OneView Monitoring System Hematocrit / Oxygen Saturation Probe, Catalog Number REF CD17542025-03-03
- FDACardiovascular Procedure Kits that include High Crack Check Valve PN 205307A Part Number: 6375 16010 62974 65246 66312 66342 66388 66650 66852 70472 74307 74365 74366 74430 74475 74477 74502 74773 74873 75065 75157 75195 75409 75410 75473 75533 75534 75607 75765 75797 75833 75903 75956 75973 7613...2024-02-20
- FDACAPIOX RX15 Hollow Fiber Oxygenator, Catalog Number 3CX*RX15RE302023-03-01
- FDACAPIOX NX19 Hollow Fiber Oxygenator, Catalog Number 3CX*NX19RE2023-03-01
- FDACAPIOX FX25 Hollow Fiber Oxygenator, Catalog Numbers 3CX*FX25REC, 3CX*FX25RWC2023-03-01
- FDACardiovascular Procedure Kit catalog # 76645 & 738062022-02-03
- FDATerumo Advanced Perfusion System 1 Electronic Patient Gas System Catalog #: 8011882021-06-08
Own something like this?
AllClear screens your whole list against every CPSC, FDA, USDA and NHTSA recall — and tells you the day a new one names something you own.
Start free — 200 items, no card →