Z-2791-2020 Class II Terminated
FDA device recall Z-2791-2020 was initiated by HF Acquisition Co., LLC on June 4, 2020 and is designated Class II. Reason for recall: Instead of 2 doses, packaged 1 dose of nasal spray in an emergency kits. The recall status is terminated (terminated July 8, 2022). Affected quantity: 5.
Recall Details
- Product Type
- Devices
- Report Date
- August 19, 2020
- Initiation Date
- June 4, 2020
- Termination Date
- July 8, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5
Product Description
STAT KIT Model 550AI Emergency Medical Kit. P/N: 1010830 containing various products to include Narcan Nasal spray, item number 1010300
Reason for Recall
Instead of 2 doses, packaged 1 dose of nasal spray in an emergency kits.
Distribution Pattern
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
Code Information
STAT KIT¿ 550AI ; Emergency Medical Kit P/N: 1010830 Narcan Nasal spray item number 1010300