LAERDAL Silicone Resuscitator (LSR), Pediatric Size, containing an Intake/Reservoir Valve. Sold as Part Nos: 860050-Pedi
FDA device recall Z-0518-04 · posted 2004-02-10 · Terminated
Recall details
- Recalling firm
- Laerdal Medical Corporation
- Reason for recall
- Potential for the Flap Valve component of the Intake/Reservoir Valve to become dislodged from its mount, rendering the resuscitator inoperative.
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- BTM
- Quantity affected
- 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 unk
- Date initiated
- 2003-12-23
- Date posted
- 2004-02-10
- Date terminated
- 2005-11-16
- Location
- Wappingers Falls, NY
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