H&H Emergency Cricothyrotomy Kit Recall for Weakened Tubing
H & H Associates is recalling 6,619 Emergency Cricothyrotomy Kits because the medical device tubing may become weakened and ineffective.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class I, which mandates a minimum severity score of 4 per the rubric.
Plain-English summary
H & H Associates is recalling 6,619 Emergency Cricothyrotomy Kits (Part No. HHECT01/HHECTK01) distributed nationwide. The recall is due to a defect where the medical device tubing used for endotracheal airway application may become weakened and rendered ineffective.
The affected kits are vacuum sealed and packaged in 5 mil poly bags. Specific lot numbers and expiration dates range from August 2015 to July 2016, including lots such as CKBD033, CKBP045, and CKBY080.
Consumers and healthcare facilities should stop using the affected kits and contact the manufacturer for further instructions.
The recalled product
- Product
- H&H Emergency Cricothyrotomy Kit (Part No. HHECT01/ HHECTK01, NSN 6515-01-573-0692), vacuum sealed and packaged in a 5 mil poly bags, labeled in part ***H & H Associates, Inc. CAGE 1NNH6 www.gohandh.com Ordinary, VA 23131 (800) 326-5708***. The product is used to maintain…
- Manufacturer
- H & H Associates
- Hazard
- Affected units
- 6,619
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 (9)
- Lots\EXP Dates: CKBD033
- CKBE033 August 2015 CKBD034
- CKBF034
- CKBG034 August 2015 CKBP045 November 2015 CKBP047
- CKBQ047 November 2015 CKBR060 February 2016 CKBT065 April 2016 CKBV070
- CKBW070
- CKBY079 July 2016 CKBY080
- CKBZ080
- CKCA080 July 2016.
Distribution
Distributed nationwide across the United States.
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