CARDINAL HEALTH 30635-611Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00630140015680), received between Aug 9, 2017 and Mar 12, 2018 — classified as 2 injuries.

The most frequently reported specific device problem is “Leak/Splash” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMar 12, 2018Material Rupture

  BASED ON INFORMATION RECEIVED FROM THE CUSTOMER, ON (B)(6) 2018 A PHLEBOTOMIST SUSTAINED A SPLASH TO THE EYES AFTER A PORTA SAMPLE COLD PACK RUPTURED UPON ACTIVATION. THE PHLEBOTOMIST FLUSHED HIS EYES AND REPORTED TO EMPLOYEE HEALTH.

  Patient problems: Chemical Exposure

  MAUDE report 7331731 ↗
• InjuryAug 9, 2017Leak/Splash

  BASED ON INFORMATION FROM THE CUSTOMER, ON (B)(6)2017 ABOUT 2:40 PM, A LAB CLERK SUSTAINED AN EXPOSURE FROM THE PORTA SAMPLE COLD PACK. THE COLD PACK WAS PLACED IN A BIOHAZARD BAG WITH SPECIMEN DURING TRANSPORT, HOWEVER UPON RECEIPT THE BAG WAS LEAKING THE AMMONIUM NITRATE IN THE BIOHAZARD BAG. WHEN SHE WENT TO OPEN THE BAG TO GET THE SPECIMEN, THE AMMONIUM NITRATE SPLASHED INTO HER RIGHT EYE. SHE IMMEDIATELY RINSED AND REPORTED TO THE EMERGENCY CENTER FOR TREATMENT.

  Patient problems: Chemical Exposure

  MAUDE report 6776423 ↗