FDA Enforcement
Class II
Terminated
MEDICYCL-E- Lite Portable Oxygen System An integrated portable oxygen delivery system intended to provide supplemental oxygen to adults. The device is MRI safe, MRI-compatible, and intended for use during MR Imaging for MRI systems up to 3.0 T. For emergency use only when administered by properly trained personnel for oxygen deficiency and resuscitation. For all other medical applications, Rx only.
Recall: Z-1561-2013
·
Reported June 26, 2013
Enforcement
- Recall Number
- Z-1561-2013
- Event ID
- 64856
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Linde Gas North America Llc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- June 26, 2013
- Initiation Date
- March 8, 2013
- Classification Date
- June 20, 2013
- Termination Date
- February 3, 2015
- Address
- 575 Mountain Ave, Attn Import Compliance Manager, New Providence, NJ, 07974, United States
Description
MEDICYCL-E- Lite Portable Oxygen System An integrated portable oxygen delivery system intended to provide supplemental oxygen to adults. The device is MRI safe, MRI-compatible, and intended for use during MR Imaging for MRI systems up to 3.0 T. For emergency use only when administered by properly trained personnel for oxygen deficiency and resuscitation. For all other medical applications, Rx only.
Reason
A number of MEDICYL-e Portable Oxygen Systems may have misapplied valve flow knobs.
Code Info
Model : Manufacturer's #M70500037 Cataogue Number: 109855 Lot numbers: 25/07 48/06 20/03
Distribution
Nationwide distribution.
Quantity
52,264 units (1106 units)