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Terminated

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

FDA Recall Z-0075-2018 · Posted None

Recalling FirmTerumo BCT, Inc.
Recall StatusTerminated
Product CodeFMF
Date Initiated2017-10-20
Date Terminated2021-03-26
Product Quantity525 kits

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.

Firm 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

Root Cause

Packaging

Distribution Pattern

Nationwide Distribution including CA, CO, GA, LA, NJ, NV, NY, OR, PA, TX, and UT.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K043261HARVEST GRAFT DELIVERY SYRINGEHarvest Technologies, Corp. · 2005-03-11

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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