—#180826

Product

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

FDA product code: NGT — Saline, Vascular Access Flush
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K153481
Affected lot / code info: Lots 8353952 9011582 9017875 9024676 9045702 9060999 9079716 9127571 9143529 9156595 9163601

Why it was recalled

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

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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).

Recalling firm

Firm: Becton Dickinson & Company
Address: 1 Becton Dr, Franklin Lakes, New Jersey 07417-1815

Distribution

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

Timeline

Recall initiated: 2020-04-16
Terminated: 2021-09-01
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #180826. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.