Terumo BCT Recalls Harvest Graft Delivery Packs Due to Seal Defect
Terumo BCT is recalling 525 Harvest Graft Delivery Packs because some lots may lack a seal on the inner pouch, potentially compromising sterility.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a potential sterility breach (lack of seal), which poses a risk of harm (infection) even though no specific injuries are reported in the source text. This aligns with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Terumo BCT, Inc. is recalling 525 units of the Harvest Graft Delivery System GDP-10 Procedure Packs (REF 51449). The recall is due to a potential lack of a seal on the inner pouch in certain lots. This defect may compromise the sterile integrity of the medical device.
The affected product is a disposable pack used to hydrate bone graft material for application to sites deemed necessary by doctors. The recall covers specific batches with expiration dates ranging from March 2018 to August 2019. The products were distributed nationwide, including in California, Colorado, Georgia, Louisiana, New Jersey, Nevada, New York, Oregon, Pennsylvania, Texas, and Utah.
Healthcare providers and patients should stop using the affected lots immediately. Terumo BCT is the recalling firm. Users should verify their product lot numbers against the recall list and contact the manufacturer for further instructions.
The recalled product
- 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 si
- Manufacturer
- Terumo BCT, Inc.
- Affected units
- 525
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (10)
- UDI Case 35020583514493
- Each 05020583514492 Batch/Number: 04A9925
- Exp. 01MAR2018
- 05A9928
- Exp. 01MAY2019
- 06A9948
- Exp. 01JUN2019
- 06A9978
- 08A9950
- Exp. 01AUG2019
Distribution
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