Recall Z-2788-2020— HF Acquisition Co., LLC
Class II · Terminated
Class II FDA medical device recall by HF Acquisition Co., LLC, initiated 2020-06-04, terminated 2022-07-08. FDA's recall record names no specific 510(k) clearance for this event. 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. Reason: Instead of 2 doses, packaged 1 dose of nasal spray in an emergency kits..
- Recalling firm
- HF Acquisition Co., LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-06-04
- Terminated
- 2022-07-08
- Firm location
- Mukilteo, WA, United States
Product description
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
Reason for recall
Instead of 2 doses, packaged 1 dose of nasal spray in an emergency kits.
Data sourced from openFDA. This site is unofficial and independent of the FDA.