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 t

Is my product affected?

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 nece

• UPC 35020583514493
• UPC 05020583514492

Check against the official notice below — it lists the full affected range.

What happened

Terumo BCT, Inc. is recalling 525 units of the Harvest Graft Delivery System GDP-10 Procedure Pack (a sterile, disposable medical device) distributed nationwide because certain lots may have a lack of a seal on the inner pouch. The affected lots are: 04A9925 (expiration 01MAR2018), 05A9928 (expiration 01MAY2019), 06A9948 (expiration 01JUN2019), 06A9978 (expiration 01JUN2019), and 08A9950 (expiration 01AUG2019). Distribution included California, Colorado, Georgia, Louisiana, New Jersey, Nevada, New York, Oregon, Pennsylvania, Texas, and Utah.

The source document does not specify a remedy or what affected consumers should do in response to this recall.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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

Details from the source

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. Distribution: Nationwide Distribution including CA, CO, GA, LA, NJ, NV, NY, OR, PA, TX, and UT. Quantity: 525 kits Lot/code info: UDI Case 35020583514493, Each 05020583514492 Batch/Number: 04A9925, Exp. 01MAR2018; 05A9928, Exp. 01MAY2019; 06A9948, Exp. 01JUN2019; 06A9978, Exp. 01JUN2019; 08A9950, Exp. 01AUG2019

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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