FDAFDA · Food and drugs·Recall number Z-0674-2017
Adiprep Adipose Transfer System. Product Codes: 51431; 51432; 51433; 514001-347.
Published December 7, 2016 · Recall initiated: November 3, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Terumo BCT announces a voluntary field action for the Harvest : Adiprep Adipose Transfer System because the affected product is incorrectly labeled and has the potential for operator confusion.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Terumo BCT, Inc.
- Distributor
- Nationwide, Canadian, and other foreign consignees. No VA/govt/military consignees.
- Lot
- Product Code: 51431, Lot Codes: 07Z9913; 07Z9933; 08Z9932; 09Z9908; 10Z9908 Product Code: 51432, Lot Codes: 08Z9907; 09Z9931. Product Code: 51433, Lot Codes: 08Z9901; 08Z9933. Product Code: 514001-347, Lot Codes: 05Z9956; 05Z9956; 07Z9917; 07Z9917; 07Z9917; 07Z9917; 05Z9956; 05Z9956; 07Z9917
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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