Recall Z-2789-2020 ยท LRR First Aid Kit With Drug
HF Acquisition Co., LLC
STAT KIT, Model SM30 ; Emergency Medical Kit P/N: 1008670 containing various products to include Narcan Nasal spray, item number 1010300
| Date | Aug 12, 2020 (initiated Jun 4, 2020) |
| Status | Terminated |
| Reason | Instead of 2 doses, packaged 1 dose of nasal spray in an emergency kits. |
| Root cause | Process change control |
| Action | On June 4th, 2020, the firm sent an "URGENT: MEDICAL DEVICE RECALL" Notification to customers via UPS Priority Overnight, informing them that their emergency medical kits supplied had missing nasal spray vial inside the kit. The notification informed the customers that the Recalling Firm is supplying the 2 doses of nasal spray along with instructions to add the nasal doses to their Emergency Medical Kits and if the customer wished to return the single dose for destruction.to the firm, send in a postage paid Unused Medications Recovery Envelop. The notification included, firm's Customer Suppo |
| Quantity | 95 Kits |
| Distribution | U.S. Distribution: CA, FL, NY, AL, WA, CT, OH, MA, TX, NH, WI, ID, MN, DC, IL, MI, PA, MT, AK, NE, MD, CO, GA, VA, WY, MO, HI, SD, AR, TN, KS, ND, WV, NJ, OK, OR, ME, AZ, NC, OUS: None |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.