FDA Recall Terminated

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.

Recall: Z-0772-2014 · Initiated November 26, 2013

Recall

Recall Number
Z-0772-2014
Event Number
67098
Firm
Becton Dickinson & Company
FEI Number
2243072
Product Code
FGY
Status
Terminated
Root Cause
Packaging
Initiated
November 26, 2013
Posted
January 15, 2014
Terminated
May 6, 2016
Address
1 Becton Dr, Franklin Lakes, NJ, 07417-1815

Description

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.

Reason

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.

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.

Distribution

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

Quantity

268,500 products