Cardioplegia Solution del Nido Formula recall: Sterility Concern
Cardioplegia Solution del Nido Formula, IV Bag, Total Volume = 1,052.8 mL, FOR INTRACARDIAC PERFUSION USE ONLY, PLASMA-LYTE A 1000 mL, Mannitol 20%…
Why was Cardioplegia Solution del Nido Formula recalled?
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot: 36-252365, 36-252368, 36-252369, 36-253887, 36-253888, Exp. 8/1/2023; 36-254404, 36-254406, 36-254407, 36-254408, 36-254409, 36-254410, Exp. 8/5/2023; 36-255219, 36-255220, 36-255221, 36-255222, 36-255223, Exp. 8/7/2023; 36-255420, 36-255421, 36-255422, 36-255424, 36-255425, 36-255453, 36-255454, 36-255731, Exp. 8/8/2023; 36-247605, 36-247608, 36-247609, 36-247610, Exp. 7/10/2023; 36-255880, 36-255881, 36-255882, 36-255883, 36-255884, 36-255885, 36-255887, 36-256004, Exp. 8/11/2023; 36-247819, 36-247820, 36-247821, 36-247822, Exp. 7/11/2023; 36-256108, 36-256109, 36-256110, 36-256111, 36-256112, 36-256113, Exp. 8/12/2023; 36-248139, 36-248142, 36-248143, 36-248144, Exp. 7/12/2023; 36-256326, 36-256327, 36-256328, 36-256329, 36-256330, 36-256331, Exp 8/13/2023; 36-256701, 36-257025, Exp. 8/14/2023; 36-248303, 36-248304, 36-248305, 36-248306, 36-248316, Exp. 7/14/2023; 36-248509, 36-248511, 36-248513, 36-248514, Exp. 7/15/2023; 36-248815, 36-248816, 36-248817, 36-248818, Exp. 7/16/2023; 36-248962, 36-248964, 36-248966, Exp. 7/17/2023; 36-249216, 36-249220, 36-249222, Exp. 7/18/2023; 36-249575, 36-249576, 36-249577, Exp. 7/19/2023; 36-249631, 36-249632, Exp. 7/21/2023; 36-249836, Exp. 7/22/2023; 36-250033, 36-250034, 36-250035, Exp. 7/23/2023; 36-250388, 36-250391, Exp. 7/24/2023; 36-251697, 36-251699, 36-251700, Exp. 7/30/2023; 36-252078, 36-252079, 36-252080, Exp. 7/31/2023.
- Product
- Cardioplegia Solution del Nido Formula, IV Bag, Total Volume = 1,052.8 mL, FOR INTRACARDIAC PERFUSION USE ONLY, PLASMA-LYTE A 1000 mL, Mannitol 20%…
- Recalling firm
- Central Admixture Pharmacy Services, Inc.
- Quantity
- 10,480 bags
- Distribution
- Nationwide in the USA
- Recall date
- August 9, 2023
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)