Z-2209-2019 Class II Terminated
FDA device recall Z-2209-2019 was initiated by Bard Peripheral Vascular Inc on May 2, 2019 and is designated Class II. Reason for recall: There has been an increase in complaints related to leaks, suction issues, and failure to obtain samples while using the product. The recall status is terminated (terminated March 3, 2022). Affected quantity: 36,640 units.
Recall Details
- Product Type
- Devices
- Report Date
- August 14, 2019
- Initiation Date
- May 2, 2019
- Termination Date
- March 3, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 36,640 units
Product Description
Reason for Recall
Distribution Pattern
Worldwide distribution - US Nationwide distribution, including Puerto Rico. There was government and foreign distribution and no military distribution. Foreign distribution was made to Canada, Algeria, Australia, Austria, Belgium, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Egypt, Finland, France, Georgia, Germany, Gibraltar, Greece, Guadeloupe, Hungary, Iceland, India, Ireland, Italy, Japan, Korea, Kuwait, Luxembourg, Malaysia, Martinique, Monaco, Netherlands, New Zealand, Norway, Poland, Portugal, Qatar, Reunion, Russia, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom, and Viet Nam.