CARDINAL HEALTH
Received Feb 10, 2026 · Event occurred Jan 30, 2026
Report 3004824601-2026-00016 · MDR key 24304550
Device
Generic name
Stat, Specimen Transport Bag
Manufacturer
Heng Rong Plastic Products CompanyModel number
CH6X9STATProduct problems
- Product Quality Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
AFTER INVESTIGATION OF RETURNED SAMPLE, IT WAS DETERMINED THAT THE ROOT CAUSE HAS PREVIOUSLY BEEN ADDRESSED THROUGH A PREVIOUS INVESTIGATION (DOCUMENTED WITHIN SCAR-19-00332) RELATED TO BAGS TEARING AT THE TOP ZIPPER PORTION. DUE TO THE LOT NUMBER NOT BEING PROVIDED, IT CANNOT BE DETERMINED IF THIS COMPLAINT WAS MADE BEFORE OR AFTER THE INVESTIGATION CORRECTIONS. WE WILL CONTINUE TO TRACK AND TREND FOR ANY ADDITIONAL REPORTED EVENTS. ADDITIONALLY, FROM THE CUSTOMER'S FEEDBACK IT APPEARS THAT THEY ARE USING THE DEFECTIVE PRODUCT INSTEAD OF DISCARDING IT PRIOR TO USE. CUSTOMER HAS BEEN ADVISED TO DISCARD ANY DEFECTIVE PRODUCTS PRIOR TO USE. NO REPORTED ADVERSE EVENTS WERE REPORTED.
Description of Event or Problem
ON (B)(6) 2026, CUSTOMER EMAILED THAT THE RECENT BATCH THE CURRENTLY ARE USING ARE NOT OPENING PROPERLY. WE ARE UNABLE TO UNZIP THEM, OFTEN TEARING THE TOP OFF. WE HAVE SENT A FEW TO LAB WITHOUT BEING COMPLETELY CLOSED. NO ADVERSE EVENTS WERE REPORTED.