Lot numbers were not provided. All product shipped after 1/29/2003 is affected. Customers need to visually examine the Intake/Reservoir valve in order to determine if they have affected product.
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.
Description du dispositif
Intake/Reservoir Valve (Part No. 875400), used in all sizes of Laerdal Silicone Resuscitators. Responsible firm on the label: Distributed in the U.S. by Laerdal Medical Corporation, Wappingers Falls, NY, Made in Norway.
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 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.
Description du dispositif
LAERDAL Silicone Resuscitator (LSR), Preterm Size, containing an Intake/Reservoir Valve. Sold as Part Nos: 850050-Preterm Basic w/o Mask in Carton; 850051-Preterm Complete in Carton; 850053-Preterm Complete in Compact Case; 850055-Preterm Complete in Display Case; 855500-Preterm Update Kit. Responsible firm on the label: Distributed in the U.S. by Laerdal Medical Corporation, Wappingers Falls, NY, Made in Norway.
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 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.
Description du dispositif
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.
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 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.
Description du dispositif
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.