Z-0772-2014Class II

BD Interlink threaded lock cannula This is a locking blunt plastic cannula specifically designed for IV...

Name: Z-0772-2014 BD Interlink threaded lock cannula This is a locking blunt plastic cannula specifically designed for IV...
Creator: Becton Dickinson & Company
Published: 2013-11-26
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2013-11-26 / Terminated / root cause: packaging

FDA source

Becton Dickinson & Company began a recall of BD Interlink threaded lock cannula This is a locking blunt plastic cannula specifically designed for IV connection to an Interlink injection site. It is... on 2013-11-26. FDA classified it as Class II and gives the reason as "BD Interlink Threaded Lock Cannula REF# 303369 and lot #3021392 is being recalled due to the potential that a small percentage of the lot may exhibit open seals which adversely impacts unit package integrity and product...". 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-0772-2014
Classification: Class II
Status: Terminated
Initiated: 2013-11-26
Posted: 2014-01-15
Terminated: 2016-05-06
Recalling firm: Becton Dickinson & Co
Product: BD Interlink threaded lock cannula This is a locking blunt plastic cannula specifically designed for IV connection to an Interlink injection site. It is screwed down over the Interlink injection site and a blunt plastic cannula inside the housing enters the Interlink injection site to provide a pathway for IV fluid administration.
Product code: FGY Cannula, Injection
Reason for recall: BD Interlink Threaded Lock Cannula REF# 303369 and lot #3021392 is being recalled due to the potential that a small percentage of the lot may exhibit open seals which adversely impacts unit package integrity and product sterility.
Root cause tag: packaging
FDA root cause: Packaging
Action: BD Diagnostics sent an Urgent: Voluntary Product Recall letters/Notice of Return dated November 26, 2013, to all affected customers. Customers were asked to identify and segregate stock of the affected number, inform the appropriate personnel in their organization to discontinue use of the affected product, return the afected product, following the instructions on the enclosed packing slip, BD would issue a credit for product returned. If product was further distributed customers were instructed to identify their customers and notify them at once of the product recall using the provided customer communication. Customers were asked to complete the attached notice and fax to 855-731-0157. Customers with questions were instructed to call 1-855-731-0157. For questions regarding this recall call 755-731-0157.
Quantity in commerce: 268,500 products
Distribution: Worldwide Distribution - USA (nationwide) and Internationally to Canada and Japan.
Product codes and lots: Marketing Status: Class II, 510K # K011858 Device Listing Number: D043644 Lot number 3021392

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0772-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0772-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-22	2014-01-15

Product code FGY

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)