—#124695

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.

FDA product code: FGY — Cannula, Injection
Device class: Class 1
Medical specialty: General, Plastic Surgery
Affected lot / code info: Marketing Status: Class II, 510K # K011858 Device Listing Number: D043644 Lot number 3021392

Why it was recalled

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 (FDA determination)

Packaging

Action the firm took

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.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution - USA (nationwide) and Internationally to Canada and Japan.

Timeline

Recall initiated: 2013-11-26
Posted by FDA: 2014-01-15
Terminated: 2016-05-06
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #124695. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.