The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2790-2020·Announced 2020-08-19

HF Acquisition Recalls STAT KIT 550 Emergency Medical Kits

HF Acquisition Co., LLC is recalling 155 STAT KIT Model 550 Emergency Medical Kits because they contain one dose of Narcan Nasal spray instead of two.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any illnesses, injuries, or hospitalizations. The hazard is a packaging error resulting in a lower quantity of medication than intended, which fits the criteria for a moderate severity score.

Plain-English summary

HF Acquisition Co., LLC is recalling 155 units of the STAT KIT Model 550 Emergency Medical Kit (P/N: 1009580). The recall is due to a packaging error where the kits contain only one dose of Narcan Nasal spray (item number 1010300) instead of the required two doses.

The affected kits were distributed in the United States to the following states and districts: 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, and NC. No international distribution is reported.

Consumers who possess these kits should stop using them and contact the recalling firm for instructions on how to return the product or obtain a replacement.

The recalled product

Product
STAT KIT Model 550 Emergency Medical Kit P/N: 1009580 containing various products to include Narcan Nasal spray, item number 1010300
Manufacturer
HF Acquisition Co., LLC
Category
Medical Device — Emergency Medical Kit
Hazard
Affected units
155

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

  • STAT KIT¿ 550
  • Emergency Medical Kit P/N: 1009580 Narcan Nasal spray
  • item number 1010300

Distribution

Distributed in 39 states:

Part of a larger recall action

This product is one of 4 recalled by HF Acquisition Co., LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

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