Z-0621-2013 Class I Terminated
FDA device recall Z-0621-2013 was initiated by Fisher & Paykel Healthcare, Ltd. on November 19, 2012 and is designated Class I. Reason for recall: FPH has become aware that one batch of tubes supplied to FPH may contain hole damage. These tubes were incorporated by FPH into certain 900MR068 reusable circuits with lot numbers 110810 and 111020. I… The recall status is terminated (terminated July 11, 2013). Affected quantity: 200 units total, 26 units US.
Recall Details
- Product Type
- Devices
- Report Date
- January 9, 2013
- Initiation Date
- November 19, 2012
- Termination Date
- July 11, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 200 units total, 26 units US
Product Description
Fisher & Paykel Healthcare reusable breathing circuit. Non-heated breathing circuit, 1.8m or 6 feet in length. Oxygen therapy delivery system for adult patient.
Reason for Recall
FPH has become aware that one batch of tubes supplied to FPH may contain hole damage. These tubes were incorporated by FPH into certain 900MR068 reusable circuits with lot numbers 110810 and 111020. If this hole damage is not detected during the standard leak test before patient use, it could potentially result in a gas leak in the breathing system, which may lead to a loss of pressure for the int
Distribution Pattern
Worldwide Distribution - USA including IL, IN, AR and GA.
Code Information
Lots 110810 and 111020