Z-1458-2015 Class II Terminated
FDA device recall Z-1458-2015 was initiated by Del Mar Reynolds Medical, Ltd. on March 5, 2015 and is designated Class II. Reason for recall: Reports of inaccurate low flow readings. Monitored inspiratory tidal volume (VTi) and expiratory tidal volume (Vte) measurements from the pediatric flow sensor are reporting out of specification low c… The recall status is terminated (terminated November 16, 2015). Affected quantity: 1040 units total (398 in the US and 642 international).
Recall Details
- Product Type
- Devices
- Report Date
- April 29, 2015
- Initiation Date
- March 5, 2015
- Termination Date
- November 16, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1040 units total (398 in the US and 642 international)
Product Description
Reason for Recall
Distribution Pattern
Worldwide Distribution-US including the states of Louisiana, North Carolina, and Washington and the countries of Argentina, Brazil, China, Colombia, Ecuador, Finland, Great Britain, India, Libya, Mexico, Nicaragua, Oman, Philippines, Saudi Arabia, Slovakia, Sri Lanka, United Arab Emirates, and Vietnam.