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Class 2 Device Recall HealthFirst Emergency Kit SM 7 |
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Date Initiated by Firm |
June 04, 2020 |
Date Posted |
August 12, 2020 |
Recall Status1 |
Terminated 3 on July 08, 2022 |
Recall Number |
Z-2788-2020 |
Recall Event ID |
85911 |
Product Classification |
First Aid Kit with drug - Product Code LRR
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Product |
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 |
Code Information |
SM7 (NARCAN Upgrade Bundle): P/N: 1008150 SM7 Emergency Medical Kit |
Recalling Firm/ Manufacturer |
HF Acquisition Co., LLC 11629 49th Pl W Mukilteo WA 98275-4255
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For Additional Information Contact |
Jason March 800-331-1984
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Manufacturer Reason for Recall |
Instead of 2 doses, packaged 1 dose of nasal spray in an emergency kits.
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FDA Determined Cause 2 |
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 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. |
Quantity in Commerce |
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 |
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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