CLASS II Device recall · Reported 15 Nov 2017 · FDA Enforcement Report

Harvest Terumobct, Gcp-10 Graft Delivery Pack recalled

Terumo BCT is recalling Harvest Terumobct, Gcp-10 Graft Delivery Pack, distributed nationwide in the US. The recall was initiated on 20 Oct 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI Case 35020583514493, Each 05020583514492 Batch/Number: 04A9925, Exp. 01MAR2018; 05A9928, Exp. 01MAY2019; 06A9948, Exp. 01JUN2019; 06A9978, Exp. 01JUN2019; 08A9950, Exp. 01AUG2019

Quantity recalled525 kits

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0075-2018
FDA event ID: 78309
Recalling firm: Terumo BCT, Lakewood, CO
Classification: Class II
Status: Terminated
Recall initiated: 20 Oct 2017
FDA classified: 8 Nov 2017
Reported: 15 Nov 2017
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Other Medical Devices

Timeline

20 Oct 2017	Recall initiated by company
8 Nov 2017	Classified by FDA	+19 days
15 Nov 2017	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

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

Where it was distributed

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

Nationwide California Colorado Georgia Louisiana New Jersey Nevada New York Oregon Pennsylvania Texas Utah

Questions about this recall

Why was it recalled?

Certain lots of the Harvest Graft Delivery System GDP-10 Procedure Packs may have a lack of a seal on the inner pouch.

Which lots are affected?

UDI Case 35020583514493, Each 05020583514492 Batch/Number: 04A9925, Exp. 01MAR2018; 05A9928, Exp. 01MAY2019; 06A9948, Exp. 01JUN2019; 06A9978, Exp. 01JUN2019; 08A9950, Exp. 01AUG2019

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Terumo BCT

All 4

Reported	Class	Recall	Company	Reason	Where
22 Nov 2017Device	CLASS II	Harvest(R) Terumobct, BMAC2-120-01Bone Marrow Procedure Pack recalled	Terumo BCT	Sterility	7 states
22 Nov 2017Device	CLASS II	Harvest(R) Terumobct, Bmac-30-07 Bone Marrow Procedure Pack recalled	Terumo BCT	Sterility	7 states
7 Dec 2016Device	CLASS II	Adiprep Adipose Transfer System recalled by Terumo BCT	Terumo BCT	Labeling Errors	Nationwide

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