The Recall Desk
HighFDA (Drugs)·D-1037-2023·Announced 2023-08-09

Cardioplegia Solution Recalled Due to Sterility Assurance Failure

Central Admixture Pharmacy Services is recalling 356 bags of cardioplegia solution distributed nationwide. The recall is due to lack of assurance of sterility, as validation data for decontamination cycles is lacking.

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 high-risk injectable product used directly in critical cardiac surgery where sterility is essential. The recall is based on lack of sterility assurance (validation data for decontamination cycles is lacking). However, no illnesses or injuries have been reported and no contamination has been confirmed, classifying this as a theoretical risk-of-harm situation and qualifying for Score 3 per the rubric.

Plain-English summary

Central Admixture Pharmacy Services, Inc. is recalling Cardioplegia Solution, low K, Maintenance 4:1 Plasmalyte (NDC: 72196-0211-1) distributed nationwide. The recall involves 356 bags.

The product is being recalled due to lack of assurance of sterility. Specifically, validation data for decontamination cycles is lacking. This validation is necessary to ensure the product is free from microbial contamination.

Cardioplegia solution is an IV medication administered directly during cardiac surgery. The affected lot numbers and expiration dates are: 36-251457 (Exp. 7/14/2023), 36-253952 (Exp. 7/20/2023), 36-255944 (Exp. 7/27/2023), and 36-257101 (Exp. 7/31/2023). Healthcare providers should reference the FDA recall notice for guidance on this product.

The recalled product

Product
Cardioplegia Solution, low K, Maintenance 4:1 Plasmalyte, Low Potassium, IV Bag, total volume = 1047 mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0211-1
Manufacturer
Central Admixture Pharmacy Services, Inc.
Category
Drug — Surgical Pharmacy / Injectable
Hazard
  • sterility-failure
  • contamination-risk

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 (8)

  • Lot: 36-251457
  • Exp. 7/14/2023
  • 36-253952
  • Exp. 7/20/2023
  • 36-255944
  • Exp. 7/27/2023
  • 36-257101
  • Exp. 7/31/2023.

Distribution

Distributed nationwide across the United States.

Related recalls

Same category