Z-2065-2020Class II

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

Name: Z-2065-2020 BD Posiflush SF Saline Flush Syringe (US Distributed Catalog 306553), UDI 50382903065535
Creator: Becton Dickinson & Company
Published: 2020-04-16
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2020-04-16 / Terminated / root cause: packaging

FDA source

Becton Dickinson & Company began a recall of BD Posiflush SF Saline Flush Syringe (US Distributed Catalog 306553), UDI 50382903065535 on 2020-04-16. FDA classified it as Class II and gives the reason as "This product has been confirmed to exhibit holes in the packaging, which impacts package integrity and potentially compromises a sterile field". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2065-2020
Classification: Class II
Status: Terminated
Initiated: 2020-04-16
Posted: 2020-05-21
Terminated: 2021-09-01
Recalling firm: Becton Dickinson & Co
Product: BD Posiflush SF Saline Flush Syringe (US Distributed Catalog 306553), UDI 50382903065535
Product code: NGT Saline, Vascular Access Flush
Reason for recall: This product has been confirmed to exhibit holes in the packaging, which impacts package integrity and potentially compromises a sterile field.
Root cause tag: packaging
FDA 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 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
Product codes and lots: Lots 8353952 9011582 9017875 9024676 9045702 9060999 9079716 9127571 9143529 9156595 9163601

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2065-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2065-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-27	2020-05-20

Product code NGT

K153481Class II0.9% Sodium Chloride Injection, USP BD PosiFlush SF SyringeBecton, Dickinson and Company / cleared 2016-04-04

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)