Description of Event or Problem · 1
THE "EPI-SAFE KIT" IS A COMBINATION PRODUCT (DRUG+DEVICE) MANUFACTURED BY CURAPLEX (SARNOVA). THE PRODUCT APPEARS TO NOT BE REGISTERED AND USES A SYRINGE THAT IS NOT FDA APPROVED FOR DOSING CHILDREN, AND OFF-LABEL FOR DRUG INDUCED IN THE KIT (EPINEPHRINE). THE PRODUCT WAS RECALLED, HOWEVER THE MFR IS INSTRUCTING END-USERS TO "REFURBISH" THE KIT THEMSELVES AND TO "NOT RETURN" THE KITS OR DEVICES TO THE MFR. MOREOVER, THE MFR HAS MADE IT UNCLEAR AND COMPLICATED FOR PEOPLE TO RETURN THE PRODUCT (KIT), (B)(6). THIS MISCOMMUNICATION, AS WELL AS A LACK OF CLARITY REGARDING THE DANGER OF THIS PRODUCT (CAN BE GIVEN WRONG ROUTE AND IS THE WRONG DOSE FOR CHILDREN "OFF-LABEL"), HAS LED TO END-USERS HOLDING ON TO THESE KITS AND SAYING THERE IS NOTHING WRONG WITH THEM, THAT THE FDA IS IN ERROR AND THAT THEY SHOULD BE USED ON CHILDREN, EVEN MANDATING TO USE ON CHILDREN. (B)(6). THE MFR SHOULD MAKE THE EFFORT TO TAKE BACK THESE DANGEROUS MEDICAL DEVICES AND FAULTY KITS, TO MAKE SURE NO CHILDREN ARE HARMED BY THEIR OFF-LABEL USE. DOSE OR AMOUNT: 0.15 MG, FREQUENCY: PRN, ROUTE: INTRAVENOUS. DIAGNOSIS OR REASON FOR USE: ANAPHYLAXIS. IS THE PRODUCT COMPOUNDED? NO; IS THE PRODUCT OVER-THE-COUNTER? NO.