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RECALL NOTICE: AmerisourceBergen Epinephrine 1 mg PFS Medication

URGENT SAFETY NOTICE -  STRYKER HAS ISSUED A VOLUNTARY RECALL FOR HEARTSINE SAMARITAN PAD-PAK-01, PAD-PAK-02, AND PAD-PAK-07 AED ACCESSORIES WITH EXPIRATION DATES BETWEEN APRIL 17, 2025, AND AUGUST 1, 2029. THIS RECALL AFFECTS UNITS IN THE UNITED STATES DUE TO POTENTIAL BENT LOCATOR PIN DEFECTS THAT MAY PREVENT PROPER DEVICE OPERATION DURING EMERGENCY USE. MEDAIRE HAS IMPLEMENTED COMPREHENSIVE INSPECTION PROTOCOLS FOR ALL HEARTSINE UNITS SHIPPING AFTER OCTOBER 6, 2025.

UPDATED: April 8, 2026

RECALL OVERVIEW

AmerisourceBergen has issued a recall for Epinephrine 1 mg PFS 10 × 10 mL. This recall may affect some medical kits that contain this medication.

Affected Products:

  • Epinephrine 1 mg PFS 10 × 10 mL
  • Lot Number: EA038A5
  • Expiration Date: 08/31/2026
  • NDC/UPC: 7632933181
  • Issue: Potential microbial contamination
  • Regulatory notification: Tracking Number 4712.1

MEDAIRE'S PROACTIVE RESPONSE

For all customers: No action required. MedAire has taken comprehensive steps to ensure continued medical support and patient safety without disruption to in-flight operations.

All MedLink physicians supporting your aircraft have been formally notified of this recall. Your equipment continues to provide full medical capability through alternative treatment protocols.

MEDAIRE ACTIONS TAKEN

Physician Notification: Complete

All MedLink physicians have been formally notified of this recall and are prepared to provide appropriate medical guidance.

  • Epinephrine 1 mg PFS 10 × 10 mL will not be recommended by MedLink physicians for use during an in-flight medical event until further notice
  • MedLink physicians are fully prepared to recommend appropriate alternative medications or treatment pathways when clinically indicated
  • Continued medical support ensured without operational disruption

MANUFACTURER RECALL DETAILS

Tracking Number: 4712.1

Manufacturer: INTL Medication Sys Ltd/PGN, 11480 6th St, Rancho Cucamonga, CA 91730-6023

  • Recall Reason: Potential microbial contamination

  • Recall Level: Retail level

  • Recall Class: Unclassified

  • Official Recall Notice:  Read Here

Manufacturer Support:

Amphastar Customer Service: 1-800-423-4136
Email: info@amphastar.com

Important Note: There is no action required on your part at this time. MedAire has implemented all necessary protocols to ensure continued medical support.