Z-0518-04

LAERDAL Silicone Resuscitator (LSR), Pediatric Size, containing an Intake/Reservoir Valve. Sold as Part Nos...

Name: Z-0518-04 LAERDAL Silicone Resuscitator (LSR), Pediatric Size, containing an Intake/Reservoir Valve. Sold as Part Nos...
Creator: Laerdal Medical Corporation
Published: 2003-12-23
License: https://open.fda.gov/license/

Laerdal Medical a/S / initiated 2003-12-23 / Terminated

FDA source

Laerdal Medical Corporation began a recall of LAERDAL Silicone Resuscitator (LSR), Pediatric Size, containing an Intake/Reservoir Valve. Sold as Part Nos: 860050-Pediatric Basic w/o Mask in Carton... on 2003-12-23. The reason FDA records is "Potential for the Flap Valve component of the Intake/Reservoir Valve to become dislodged from its mount, rendering the resuscitator inoperative". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0518-04
Status: Terminated
Initiated: 2003-12-23
Posted: 2004-02-10
Terminated: 2005-11-16
Recalling firm: Laerdal Medical a/S
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.
Product code: BTM Ventilator, Emergency, Manual (Resuscitator)
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 root cause: 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.
Product codes and lots: 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.

Product code BTM

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)