Class 2 Device Recall BD PosiFlush SF Saline Flush Syringes

• Date Initiated by Firm: April 16, 2020
• Create Date: May 21, 2020
• Recall Status: Terminated on September 01, 2021
• Recall Number: Z-2065-2020
• Recall Event ID: 85432
• 510(K)Number: K153481
• Product Classification: Saline, vascular access flush - Product Code NGT
• Product: BD Posiflush SF Saline Flush Syringe (US Distributed Catalog 306553), UDI 50382903065535
• Code Information: Lots 8353952 9011582 9017875 9024676 9045702 9060999 9079716 9127571 9143529 9156595 9163601
• Recalling Firm/ Manufacturer: Becton Dickinson & Company; 1 Becton Dr; Franklin Lakes NJ 07417-1815
• For Additional Information Contact: Regional Customer Quality; 888-237-2762
• Manufacturer Reason for Recall: This product has been confirmed to exhibit holes in the packaging, which impacts package integrity and potentially compromises a sterile field.
• FDA Determined 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 Customer Response Form, to the contact on the form confirming acknowledgement of the notification and request replacement for all discarded product. 4. Report any adverse health consequences experienced with the use of this product to BD. Actions Taken by BD: 1. Corrective actions have been implemented at the manufacturing site to address this issue. 2. As BD is currently experiencing backorders for this product due to increased demand, they are maximizing production to help reduce the impact to customers. 3. BD will work diligently to prioritize the replacement of product to customers affected by the recall. Please complete the Customer Response Form to assure BD is aware of your replacement needs. If you have questions about this recall, you may reach BD Regional Customer Quality at 888-237-2762 OPT 4, OPT 2; Monday through Friday, between 8AM and 5PM (CT).
• Quantity in Commerce: 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
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = NGT