Z-2159-2018 Class II Terminated
FDA device recall Z-2159-2018 was initiated by Maquet Cardiopulmonary Ag on May 14, 2018 and is designated Class II. Reason for recall: This lot of arterial cannula may have been supplied with 3/8-width de-airing plugs that could break during the process of removal from the arterial cannula. The recall status is terminated (terminated May 15, 2020). Affected quantity: 40 US.
Recall Details
- Product Type
- Devices
- Report Date
- June 20, 2018
- Initiation Date
- May 14, 2018
- Termination Date
- May 15, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 40 US
Product Description
Reason for Recall
Distribution Pattern
Worldwide distribution including US state of VA and Puerto Rico, Australia, Belgium, Brazil, Canada, Chile, Colombia, Cuba, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Germany, Iran, Ireland, Israel, Italy, Japan, Lebanon, Malaysia, Martinique, Mauritius, Mexico, Netherlands, New Zealand, Norway, Pakistan, Poland, Portugal, Reunion, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Syria, Thailand, Turkey, United Arab Emirates, and United Kingdom.