FDAClass IIMay 27, 2020

BD Posiflush SF Saline Flush Syringe recall

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

Why was BD Posiflush SF Saline Flush Syringe recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lots 8353952 9011582 9017875 9024676 9045702 9060999 9079716 9127571 9143529 9156595 9163601

Product
BD Posiflush SF Saline Flush Syringe (US Distributed Catalog 306553), UDI 50382903065535
Recalling firm
Becton Dickinson & Company
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
Recall date
May 27, 2020
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls