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Class 2 Device Recall HARVEST TERUMOBCT, GCP10 Graft Delivery Pack |
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| Date Initiated by Firm |
October 20, 2017 |
| Create Date |
November 08, 2017 |
| Recall Status1 |
Terminated 3 on March 26, 2021 |
| Recall Number |
Z-0075-2018 |
| Recall Event ID |
78309 |
| 510(K)Number |
K043261
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| Product Classification |
Syringe, piston - Product Code FMF
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| 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 |
| Code Information |
UDI Case 35020583514493, Each 05020583514492 Batch/Number: 04A9925, Exp. 01MAR2018; 05A9928, Exp. 01MAY2019; 06A9948, Exp. 01JUN2019; 06A9978, Exp. 01JUN2019; 08A9950, Exp. 01AUG2019 |
Recalling Firm/
Manufacturer |
Terumo BCT, Inc.
10811 W Collins Ave
Lakewood CO 80215-4440
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Manufacturer Reason
for Recall |
Certain lots of the Harvest Graft Delivery System GDP-10 Procedure Packs may have a lack of a seal on the inner pouch.
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FDA Determined
Cause 2 |
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 in Commerce |
525 kits |
| Distribution |
Nationwide Distribution including CA, CO, GA, LA, NJ, NV, NY, OR, PA, TX, and UT. |
| Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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| 510(K) Database |
510(K)s with Product Code = FMF and Original Applicant = HARVEST TECHNOLOGIES, CORP.
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