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.
- Company
- Laerdal Medical Corporation
- Recall Initiated
- December 23, 2003
- Posted
- February 10, 2004
- Terminated
- November 16, 2005
- Recall Number
- Z-0519-04
- Quantity
- 1,247 units
- Firm Location
- Wappingers Falls, NY
Reason for Recall
Potential for the Flap Valve component of the Intake/Reservoir Valve to become dislodged from its mount, rendering the resuscitator inoperative.
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.
Lot / Code Info
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.
Root Cause
Other
Action Taken
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.