Reported Jan 19, 2022 · Ongoing
Medtronic Custom Perfusion kits, with the following product descriptions and corresponding model numbers: 1. CUSTOM…
Medtronic Perfusion Systems
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medtronic Perfusion Systems · 7611 Northland Dr N · Brooklyn Park, MN · 55428-1088
Is this the product you have?
48 of 48 products
| Model / number | Product as published |
|---|---|
BB10Q85R | CUSTOM PACK BB10Q85R FILTER ( ) |
BB11C01R | CUSTOM PACK BB11C01R MIDI DEEP ( ) |
B7H95R22 | CUSTOM PACK BB7H95R22 HYP MAIN ( ) |
BB7H95R25 | CUSTOM PACK BB7H95R25 HYP MAIN ( ) |
BB7H99R22 | CUSTOM PACK BB7H99R22 NEONAT ( ) |
BB7P46R4 | CUSTOM PACK BB7P46R4 316-14 ( ) |
BB7P48R4 | CUSTOM PACK BB7P48R4 14-38 ( ) |
BB7W03R8 | CUSTOM PACK BB7W03R8 CCSM NEON ( ) |
BB7W80R7 | CUSTOM PACK BB7W80R7 BASC PEDS ( ) |
BB8B09R7 | CUSTOM PACK BB8B09R7 INFANT ( ) |
BB8B09R8 | CUSTOM PACK BB8B09R8 INFANT ( ) |
BB8D40R3 | CUSTOM PACK BB8D40R3 P3/16X1/4 ( ) |
BB8Q16R | CUSTOM PACK BB8Q16R PED ART ( ) |
BB8V01R8 | CUSTOM PACK BB8V01R8 FVDL COLM ( ) |
HY2V10R33 | CUSTOM PACK HY2V10R33 ADULT ( ) |
HY3Z71R17 | CUSTOM PACK HY3Z71R17 PRIMARY ( ) |
HY3Z71R18 | CUSTOM PACK HY3Z71R18 PRIMARY ( ) |
HY4V00R24 | CUSTOM PACK HY4V00R24 ADULT ( ) |
HY6X29R12 | CUSTOM PACK HY6X29R12 CON-SUPP ( ) |
HY8L14R7 | CUSTOM PACK HY8L14R7 HYBRID ( ) |
- Lot codes and dates
48 of 48 products
Products covered by this recall Model / number Barcodes Product as published 2076300034306800763000343057Model BB10Q85R, (a) GTIN 00763000343057, Lot Numbers: 219164410, 220219784, 220822136, 222227252; (b) , Lot Numbers: 219822381, 220104257 00763000312190Model BB11C01R, , Lot Numbers: 218556144, 218790882, 219012584, 219586019 00763000250904Model B7H95R22, , Lot Numbers: 219586008, 220075503, 220476338 00763000451738Model BB7H95R25, , Lot Numbers: 221406421 00763000250911Model BB7H99R22, , Lot Numbers: 219814395, 219886115, 220143946, 220257643, 220434398 00643169380967Model BB7P46R4, , Lot Numbers: 218503747, 219975261, 220383910, 221017404, 221148797 00643169379848Model BB7P48R4, , Lot Numbers: 219073386 00643169990562Model BB7W03R8, , Lot Numbers: 219107651, 219491297, 221590546 00763000344535Model BB7W80R7, , Lot Numbers: 219380830, 219600017, 222304697, 222400044 00763000307189Model BB8B09R7, , Lot Numbers: 218613111 00763000347574Model BB8B09R8, , Lot Numbers: 219291877, 219529760, 219663957, 220095395, 220476333, 221148863, 221765951, 222227240, 222469109 00643169655461Model BB8D40R3, , Lot Numbers: 219220652, 219482298 00643169549364Model BB8Q16R, , Lot Numbers: 218657286, 221451556 00763000411312Model BB8V01R8, , Lot Numbers: 221267645 00763000299835Model HY2V10R33, , Lot Numbers: 219165752, 220104314 00763000241551Model HY3Z71R17, , Lot Numbers: 219073460 00763000353728Model HY3Z71R18, , Lot Numbers: 219435852, 220219913, 220911962 00763000082451Model HY4V00R24, , Lot Numbers: 219115980, 219436006, 219975242, 220383867 00763000280833Model HY6X29R12, , Lot Numbers: 218912023, 219061258, 219061259, 219061260, 219390708, 220075525, 220075526, 220281424, 220434431 00763000353360Model HY8L14R7, , Lot Numbers: 220075494 - Amount recalled
- 6,653 units
Where it was sold
Why it was recalled
Product is labeled as non-pyrogenic but endotoxin testing was not performed.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Medtronic Perfusion Systems recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.