Z-2065-2020 Class II Terminated
FDA device recall Z-2065-2020 was initiated by Becton Dickinson & Company on April 16, 2020 and is designated Class II. Reason for recall: This product has been confirmed to exhibit holes in the packaging, which impacts package integrity and potentially compromises a sterile field. The recall status is terminated (terminated September 1, 2021). Affected quantity: 16,099,310 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 27, 2020
- Initiation Date
- April 16, 2020
- Termination Date
- September 1, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 16,099,310 units
Product Description
BD Posiflush SF Saline Flush Syringe (US Distributed Catalog 306553), UDI 50382903065535
Reason for Recall
This product has been confirmed to exhibit holes in the packaging, which impacts package integrity and potentially compromises a sterile field.
Distribution Pattern
Nationwide domestic distribution. Foreign distribution to Austria, Belgium, Denmark, Finland, France, Germany, Italy, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland, UK, Australia, Canada, Mexico, Malaysia, New Zealand
Code Information
Lots 8353952 9011582 9017875 9024676 9045702 9060999 9079716 9127571 9143529 9156595 9163601