HealthFirst Emergency Medical Kit, Model SM 7, P/N: 1008150; Manufactured by HF Acquisition Co. LLC, 11629 49th Place We

FDA device recall Z-2788-2020 · posted 2020-08-12 · Terminated

Recall details

Recalling firm

HF Acquisition Co., LLC

Reason for recall

Instead of 2 doses, packaged 1 dose of nasal spray in an emergency kits.

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.

Root cause

Process change control

Status

Terminated

Product code

LRR

Quantity affected

2 kits of SM 7

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

Date initiated

2020-06-04

Date posted

2020-08-12

Date terminated

2022-07-08

Location

Mukilteo, WA