Z-2766-2017 Class II Terminated
FDA device recall Z-2766-2017 was initiated by Medtronic Perfusion Systems on June 22, 2017 and is designated Class II. Reason for recall: Identification of small pinholes in a single packaging configuration of sterile pouches. A total of seven different products were affected. The recall status is terminated (terminated July 22, 2020). Affected quantity: 63053 (48180 US) (14873 OUS).
Recall Details
- Product Type
- Devices
- Report Date
- August 2, 2017
- Initiation Date
- June 22, 2017
- Termination Date
- July 22, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 63053 (48180 US) (14873 OUS)
Product Description
Reason for Recall
Distribution Pattern
Worldwide Distribution - US (nationwide) Foreign: Argentina, Australia, Austria, Belgium, Bulgaria, Canada, Croatia, Denmark, El Salvador, France, Georgia, Germany, Hungary, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Macedonia, Moldova, Netherlands, New Zealand, Nigeria, Norway, Poland, Romania, Russian Federation, Slovenia, Spain, Thailand, Turkey, & United Kingdom.