Recall Z-2065-2020 ยท NGT Saline, Vascular Access Flush
Becton Dickinson & Company
BD Posiflush SF Saline Flush Syringe (US Distributed Catalog 306553), UDI 50382903065535
| Date | Apr 16, 2020 |
| Status | Terminated |
| Reason | This product has been confirmed to exhibit holes in the packaging, which impacts package integrity and potentially compromises a sterile field. |
| Root cause | Under Investigation by firm |
| Action | On April 16, 2020, the firm initiated customer notification via Urgent Medical Device Recall letters. Customers were informed that the product had been confirmed to exhibit holes in the packaging, potentially compromising a sterile field. Customers were asked to do the following: 1. Immediately review your inventory for the catalog and lot numbers specified in this notification and discard all product subject to the recall. 2. Share this recall notification with any users of the product, within your facilities, to ensure they are also aware of this recall. 3. Complete and return the attached |
| Quantity | 16,099,310 units |
| Distribution | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K153481 | 0.9% Sodium Chloride Injection, USP BD PosiFlush SF Syringe Becton, Dickinson and Company, Apr 4, 2016 |