HealthFirst Emergency Medical Kit, Model SM 7, P/N: 1008150; Manufactured by HF Acquisition Co. LLC, 11629 49th Place West/Mukilteo, WA 98275, HealthFirst.com; Store at Room Temperature. 9036-2v.5 08/2017 containing various products to include Narcan Nasal spray, item number 1010300
- Company
- Hf Acquisition Co Llc
- Recall Initiated
- June 4, 2020
- Posted
- August 12, 2020
- Terminated
- July 8, 2022
- Recall Number
- Z-2788-2020
- Quantity
- 2 kits of SM 7
- Firm Location
- Mukilteo, WA
Reason for Recall
Instead of 2 doses, packaged 1 dose of nasal spray in an emergency 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
Lot / Code Info
SM7 (NARCAN Upgrade Bundle): P/N: 1008150 SM7 Emergency Medical Kit
Root Cause
Process change control
Action Taken
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 Support team will call customers, following the acknowledgement of this notice and replacement product to confirm that the (2) Doses of Nasal Sprays have been placed into your Emergency Medical Kit. For any questions or information contact the Recalling Firm at 1-800-331-1984.