FDA Medical Device Recalls (openFDA)
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
- Recall number
- Z-0075-2018
- Recalling firm
- Terumo BCT, Inc.
- 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
- Status
- Terminated
- Initiated
- 2017-10-20
- Posted
- not on file
- Terminated
- 2021-03-26
- 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 Europe N.V. at +32.2.715.0590 or your local Terumo BCT representative, and Terumo BCT will issue a return goods authorization for product return. 3. Continue to use unaffected Harvest Graft Delivery System GDP-10 Procedure Packs in accordance with the instructions for use. 4. Distribute this notification to all Harvest Graft Delivery System GDP-10 Procedure Pack users within your organization. 5. IMPORTANT: Complete the attached acknowledgement form and return it by fax or email to Harvest Terumo BCT by 15 November 2017. Your return of the acknowledgement form is critical so we can confirm that you have received the recall notice. 6. As a reminder, please comply with the recommended practices for maintaining a sterile field as recommended by the Association of periOperative Registered Nurses (AORN) and refer to the instructions for use." Customers with questions, please contact your Terumo BCT representative or your regional Customer Support Center: U.S. Toll-Free: 1.877.3.FYI BCT (394 228) U.S.: +1.303.231.HELP (4357) Canada Toll-Free: 1.877.722.8411 Europe: +32.2.715.0590
- Quantity
- 525 kits
- Distribution
- Nationwide Distribution including CA, CO, GA, LA, NJ, NV, NY, OR, PA, TX, and UT.
- Lot, serial or model codes
- UDI Case 35020583514493, Each 05020583514492 Batch/Number: 04A9925, Exp. 01MAR2018; 05A9928, Exp. 01MAY2019; 06A9948, Exp. 01JUN2019; 06A9978, Exp. 01JUN2019; 08A9950, Exp. 01AUG2019
- 510(k) numbers
- ["K043261"]
- PMA numbers
- not on file
- Product code
- FMF
- Firm FEI
- 1000117351
- Firm city
- Lakewood
- Firm state
- CO
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28