Rappel de Device Recall H&H; Emergency Cricothyrotomy Kit

Recall

66128

Class 1

Z-0006-2014

2013-08-27

2013-10-01

Terminated

United States

2015-01-13

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=121529

Medical device tubing used for endotracheal airway application may become weakened and rendered ineffective.

H&H; Medical Corporation notified their customers by "Urgent Medical Device Recall" letter dated August 27, 2013 and advised that the cuff balloon wall may become weakened and rendered ineffective. The firm advised their customers to discontinue use and take steps to remove affected units from further use. The manufacturer will replace the current endotracheal airway and cuff within the kits identified with a new cuffed airway in its own sterile packaging. The recaller included two response forms for customers to return: The Acknowledgement of Recall Form is provided for those who can quarantine the Cricothyrotomy Kits indicated in the recall. The form confirms notification of this recall and discontinued use of affected devices and provides details regarding the accounting and quarantine of the product lots in question for return and correction. The Product Recall Replacement Part Request Form is only required when inventory quarantine is not feasible. This form acknowledges the receipt of this notification and the undersigned accepts the responsibility for affixing the replacement airways along with the instructions that H&H; Medical Corporation will provide. The undersigned also assumes the responsibility to inform users regarding the subject of this recall, requires the use of the replacement airways over the airways provided in the affected kits and requires the disposal of the airways within the kits upon opening. For questions regarding the corrective request, please contact Ms. Michelle Morgan at 804-642-3663 or at mmorgan@gohandh.com during the hours of 8:00 a.m.-4:30 p.m. Eastern Standard Time, Monday through Friday.