HARVEST recallZ-0075-2018 · Terumo BCT, Inc. · initiated Oct 20, 2017
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Terumo BCT, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
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.
FDA root cause category: Packaging
What the company is doing
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
Recall details
- Recall number
- Z-0075-2018
- Status
- Terminated
- Initiated by the company
- Oct 20, 2017
- Recalling firm
- Terumo BCT, Inc.
- Quantity
- 525 kits
- Product code
- FMF
- FDA submissions
- K043261
- Distribution
- Nationwide Distribution including CA, CO, GA, LA, NJ, NV, NY, OR, PA, TX, and UT.
Product description
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
Code information (models, lots, serial numbers)
UDI Case 35020583514493, Each 05020583514492 Batch/Number: 04A9925, Exp. 01MAR2018; 05A9928, Exp. 01MAY2019; 06A9948, Exp. 01JUN2019; 06A9978, Exp. 01JUN2019; 08A9950, Exp. 01AUG2019
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- HARVEST® 51449Terumo Bct, Inc. · Syringe, piston1 recall1 report
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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