BD Posiflush SF Saline Flush Syringe (US Distributed Catalog 306553), UDI 50382903065535

This product has been confirmed to exhibit holes in the packaging, which impacts package integrity and potentially compromises a sterile field.

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).