Cardioplegia Solution Recalled for Lack of Sterility Assurance
Central Admixture Pharmacy Services is recalling Cardioplegia Solution (100 mEq K) due to inadequate validation of decontamination processes. The recall affects 284 units distributed nationwide. Affected facilities should discontinue use and contact the manufacturer.
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: This is a Class II recall of a critical cardiac medication with inadequate sterility assurance and missing manufacturing process validation. Although no illnesses or injuries have been reported in the source text, the potential for serious harm is significant given the product's direct intravenous use during surgery, meeting the criterion for a high-risk product where injury has not yet been reported.
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling Cardioplegia Solution (100 mEq K Induction 8:1, 500 mL IV bags) due to lack of assurance of sterility and missing validation data for decontamination cycles. The product is a specialized intravenous medication used during cardiac surgery.
The recall affects three lots: Lot 36-252356 (Exp. 7/17/2023), Lot 36-254402 (Exp. 7/21/2023), and Lot 36-255218 (Exp. 7/23/2023). A total of 284 units were distributed nationwide in the United States.
Cardioplegia solution must maintain strict sterility standards as it is administered directly into the body during surgical procedures. The lack of validated decontamination procedures means the manufacturer cannot assure that the product meets required sterility standards.
Healthcare facilities that have received affected lots should stop using them immediately and contact Central Admixture Pharmacy Services, Inc. (2200 South 43rd Avenue, Phoenix, AZ 85043) for replacement instructions and guidance.
The recalled product
- Product
- CARDIOPLEGIA SOLUTION, 100 mEq K, Induction 8:1, High Potassium / Low dextrose, IV Bag, total volume = 500 mL, RX Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0107-1
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Affected units
- 284
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 (6)
- Lot: 36-252356
- Exp. 7/17/2023
- 36-254402
- Exp. 7/21/2023
- 36-255218
- Exp. 7/23/2023
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 95 recalled by Central Admixture Pharmacy Services, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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