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U.S. Department of Health and Human Services

Class 2 Device Recall BD Interlink threaded lock cannula

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 Class 2 Device Recall BD Interlink threaded lock cannulasee related information
Date Initiated by FirmNovember 26, 2013
Date PostedJanuary 15, 2014
Recall Status1 Terminated 3 on May 06, 2016
Recall NumberZ-0772-2014
Recall Event ID 67098
Product Classification Cannula, injection - Product Code FGY
ProductBD 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.
Code Information Marketing Status: Class II, 510K # K011858 Device Listing Number: D043644  Lot number 3021392
Recalling Firm/
Manufacturer		 Becton Dickinson & Company
1 Becton Dr
Franklin Lakes NJ 07417-1815
For Additional Information Contact
855-731-0157
Manufacturer 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.
FDA Determined
Cause 2		Packaging
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 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 Commerce268,500 products
DistributionWorldwide Distribution - USA (nationwide) and Internationally to Canada and Japan.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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