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U.S. Department of Health and Human Services

Class 2 Device Recall STAT KIT 550AI

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  Class 2 Device Recall STAT KIT 550AI see related information
Date Initiated by Firm June 04, 2020
Date Posted August 12, 2020
Recall Status1 Terminated 3 on July 08, 2022
Recall Number Z-2791-2020
Recall Event ID 85911
Product Classification First Aid Kit with drug - Product Code LRR
Product STAT KIT Model 550AI Emergency Medical Kit. P/N: 1010830 containing various products to include Narcan Nasal spray, item number 1010300
Code Information STAT KIT¿ 550AI ; Emergency Medical Kit P/N: 1010830  Narcan Nasal spray item number 1010300
Recalling Firm/
Manufacturer		 HF Acquisition Co., LLC
11629 49th Pl W
Mukilteo WA 98275-4255
For Additional Information Contact Jason March
800-331-1984
Manufacturer Reason
for Recall		 Instead of 2 doses, packaged 1 dose of nasal spray in an emergency kits.
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 5
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
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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