Recall Z-0006-2014— H & H Associates
Class I · Terminated
Class I FDA medical device recall by H & H Associates, initiated 2013-08-27, terminated 2015-01-13. FDA's recall record names no specific 510(k) clearance for this event. 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 fracture alignment.. Reason: Medical device tubing used for endotracheal airway application may become weakened and rendered ineffective..
- Recalling firm
- H & H Associates
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2013-08-27
- Terminated
- 2015-01-13
- Firm location
- Ordinary, VA, United States
Product description
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 fracture alignment.
Reason for recall
Medical device tubing used for endotracheal airway application may become weakened and rendered ineffective.
Data sourced from openFDA. This site is unofficial and independent of the FDA.