The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0681-2023·Announced 2023-05-31

Cardiac Perfusion Solution Recalled for Sterility Assurance Issues

Central Admixture Pharmacy Services is recalling Modified del Nido Microplegia syringes after an FDA inspection raised concerns about their sterility. Approximately 690 syringes distributed nationwide may be affected.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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: FDA Class II recall for suspected sterility failure in a product intended for surgical use. No illnesses or injuries have been reported; the hazard remains theoretical, placing this in the High category per the severity rubric.

Plain-English summary

Modified del Nido Microplegia, a cardiac perfusion solution used in heart surgery, is being recalled by Central Admixture Pharmacy Services, Inc. The recall was initiated after an FDA inspection questioned the sterility of the product, which is meant to be sterile for surgical use.

Approximately 690 syringes were distributed nationwide in 40 mL units. The affected product (NDC 71285-0219-1) includes the following lot numbers and expiration dates: Lot 37-893821 (Exp 04/28/2023); 37-894813 and 37-894815 (Exp 04/30/2023); 37-895489 and 37-895490 (Exp 05/05/2023); 37-897810 and 37-897811 (Exp 05/13/2023); and 37-899585 (Exp 05/20/2023).

This recall affects healthcare facilities and providers nationwide. Anyone with affected syringes should verify inventory against the lot numbers and expiration dates listed above and refrain from using affected units.

The recalled product

Product
Modified del Nido Microplegia, packaged in 40 mL per syringe, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0219-1.
Manufacturer
Central Admixture Pharmacy Services, Inc.
Category
Drug — Cardiac Perfusion Solution
Hazard
Affected units
690

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 (13)

  • Lot # 37-893821
  • Exp 04/28/2023
  • 37-894813
  • 37-894815
  • Exp 04/30/2023
  • 37-895489
  • 37-895490
  • Exp 05/05/2023
  • 37-897810
  • 37-897811
  • Exp 05/13/2023
  • 37-899585
  • Exp 05/20/2023

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 108 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.

See all 108 products in this recall →

Related recalls

Same manufacturer · Central Admixture Pharmacy Services, Inc.

See all →

Same hazard · contamination risk

See all →

Similar recalls