Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

LAERDAL Silicone Resuscitator (LSR), Adult size, containing Intake/Reservoir Valve. Sold as Part Nos: 870050-Adult Basic w/o Mask in Carton; 870051-Adult Complete in Carton; 870052-Adult Standard with Adult Mask 4-5+ in Carton; 870053-Adult Complete in Compact Case; 870055-Adult Complete in Display Case; 875500-Adult Update Kit. Responsible firm on the label: Distributed in the U.S. by Laerdal Medical Corporation, Wappingers Falls, NY, Made in Norway.

FDA Recall Z-0517-04 · Posted 2004-02-10

Recalling FirmLaerdal Medical Corporation
Recall StatusTerminated
Product CodeBTM
Date Initiated2003-12-23
Date Terminated2005-11-16
Product Quantity2,153 units

Reason for Recall

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

Firm 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.

Root Cause

Other

Distribution Pattern

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑