Medtronic Custom Perfusion kits, with the following product descriptions and corresponding model numbers: 1. CUSTOM PACK BB10Q85R FILTER (Model BB10Q85R); 2. CUSTOM PACK BB11C01R MIDI DEEP (Model BB11C01R); 3. CUSTOM PACK BB7H95R22 HYP MAIN (Model B7H95R22); 4. CUSTOM PACK BB7H95R25 HYP MAIN (Model
Check against the official notice below — it lists the full affected range.
Medtronic is recalling approximately 6,653 units of Medtronic Custom Perfusion kits across multiple model numbers. The products are labeled as non-pyrogenic (not capable of causing fever), but endotoxin testing was not performed on them. Endotoxins are bacterial substances that can trigger inflammatory responses in patients. The affected kits were distributed worldwide, including across the United States in Alabama, Arkansas, California, Connecticut, Illinois, Indiana, Kentucky, Massachusetts, Maine, Mississippi, New York, Ohio, Rhode Island, Tennessee, Texas, and Virginia, as well as in Canada, Colombia, France, Germany, Italy, the Netherlands, Saudi Arabia, and Spain.
The recall affects 17 different model numbers with specific lot numbers provided for each. Affected consumers should check if they have any of these products by comparing their model number and lot number against the detailed list provided in the recall notice. The source does not specify what remedy or action consumers should take regarding the recalled products.
Written by software from the official notice below. Not reviewed by a lawyer.
Product is labeled as non-pyrogenic but endotoxin testing was not performed.
Reason for recall: Product is labeled as non-pyrogenic but endotoxin testing was not performed. Distribution: Worldwide distribution - US Nationwide distribution in the states of AL, AR, CA, CT, IL, IN, KY, MA, ME, MS, NY, OH, RI, TN, TX, and VA. The countries of Canada, Columbia, France, Germany, Italy, Netherlands, Saudi Arabia, Spain. Quantity: 6,653 units Lot/code info: Medtronic Perfusion Kits: 1. Model BB10Q85R, (a) GTIN 00763000343057, Lot Numbers: 219164410, 220219784, 220822136, 222227252; (b) GTIN 20763000343068, Lot Numbers: 219822381, 220104257 2. Model BB11C01R, GTIN 00763000312190, Lot Numbers: 218556144, 218790882, 219012584, 219586019 3. Model B7H95R22, GTIN 00763000250904, Lot Numbers: 219586008, 220075503, 220476338 4. Model BB7H95R25, GTIN 00763000451738, Lot Numbers: 221406421 5. Model BB7H99R22, GTIN 00763000250911, Lot Numbers: 219814395, 219886115, 220143946, 220257643, 220434398 6. Model BB7P46R4, GTIN 00643169380967, Lot Numbers: 218503747, 219975261, 220383910, 221017404, 221148797 7. Model BB7P48R4, GTIN 00643169379848, Lot Numbers: 219073386 8. Model BB7W03R8, GTIN 00643169990562, Lot Numbers: 219107651, 219491297, 221590546 9. Model BB7W80R7, GTIN 00763000344535, Lot Numbers: 219380830, 219600017, 222304697, 222400044 10. Model BB8B09R7, GTIN 00763000307189, Lot Numbers: 218613111 11. Model BB8B09R8, GTIN 00763000347574, Lot Numbers: 219291877, 219529760, 219663957, 220095395, 220476333, 221148863, 221765951, 222227240, 222469109 12. Model BB8D40R3, GTIN 00643169655461, Lot Numbers: 219220652, 219482298 13. Model BB8Q16R, GTIN 00643169549364, Lot Numbers: 218657286, 221451556 14. Model BB8V01R8, GTIN 00763000411312, Lot Numbers: 221267645 15. Model HY2V10R33, GTIN 00763000299835, Lot Numbers: 219165752, 220104314 16. Model HY3Z71R17, GTIN 00763000241551, Lot Numbers: 219073460 17. Model HY3Z71R18, GTIN 00763000353728
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.