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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm December 23, 2003
Date Posted February 10, 2004
Recall Status1 Terminated 3 on November 16, 2005
Recall Number Z-0518-04
Recall Event ID 28029
Product Classification Ventilator, Emergency, Manual (Resuscitator) - Product Code BTM
Product 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.
Code Information All product shipped after 1/29/2003 is affected. The following lot numbers are the lot numbers for adult, pediatric and preterm size LSR: 0403, 0703, 0803, 0903, 1003, 1103, 1203, 1303, 1403, 1503, 1603, 1703, 1803, 1903, 2003, 2103, 2203, 2303, 2503, 2703, 2903, 3103, 3203, 3303, 3503, 3603, 3703, 3803, 3903, 4003, 4103, 4203, 4303, 4403, 4503, 4603, 4703, 4803, 4903. NOTE: customers were NOT provided with lot numbers. They were instructed to visually examine the Intake/Reservoir valve in order to determine if they have affected product.  
Recalling Firm/
Manufacturer		 Laerdal Medical Corporation
167 Myers Corners Rd
Wappingers Falls NY 12590-3827
For Additional Information Contact
800-688-4391
Manufacturer Reason
for Recall		 Potential for the Flap Valve component of the Intake/Reservoir Valve to become dislodged from its mount, rendering the resuscitator inoperative.
FDA Determined
Cause 2		 Other
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.
Quantity in Commerce 766 units
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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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