ClearanceBrief
Recall Z-0772-2014 ยท FGY Cannula, Injection

Becton Dickinson & Company

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.

DateJan 15, 2014 (initiated Nov 26, 2013)
StatusTerminated
ReasonBD 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 causePackaging
ActionBD 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 cust
Quantity268,500 products
DistributionWorldwide Distribution - USA (nationwide) and Internationally to Canada and Japan.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.