FDA Recall Terminated

LAERDAL Silicone Resuscitator (LSR), Pediatric Size, containing an Intake/Reservoir Valve. Sold as Part Nos: 860050-Pediatric Basic w/o Mask in Carton; 860051-Pediatric Complete in Carton; 860052-Standard Child w/Child Mask 3-4 in Carton; 860053-Pediatric Complete in Compact Case; 860055-Pediatric Complete in Display Case; 860056-Standard Term-Baby w/Infant Mask 0-1 in Carton; 865500-Pediatric Upgrade Kit . Responsible firm on the label: Distributed in the U.S. by Laerdal Medical Corporation, Wappingers Falls, NY, Made in Norway.

Recall: Z-0518-04 · Initiated December 23, 2003

Recall

Recall Number: Z-0518-04
Event Number: 28029
Firm: Laerdal Medical Corporation
FEI Number: 2425852
Product Code: BTM
Status: Terminated
Root Cause: Other
Initiated: December 23, 2003
Posted: February 10, 2004
Terminated: November 16, 2005
Address: 167 Myers Corners Rd, Wappingers Falls, NY, 12590-3827

Description

Reason

Potential for the Flap Valve component of the Intake/Reservoir Valve to become dislodged from its mount, rendering the resuscitator inoperative.

Action

Letters issued on 1/14/2004. The recall involves the replacement of the Inner Part of the Intake/Reservoir Valve, which is part of the Laerdal Silicone Resuscitator. Recall is to the user level.

Distribution

Product was shipped to approximately 264 customers nationwide, and 3 foreign consignees (Mexico, Brazil and Northern Mariana Islands). Product was also sold to a few exporters who shipped units to unknown countries. Customers include distributors and end users. There were 2,403 parts shipped to Laerdal Medical Canada, Ltd., Toronto, Ontario, Canada. That firm is responsible for conducting an independent recall, reportedly with the knowledge of the Canadian government.

Quantity

766 units