Device 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.
Z-0772-2014
Product summary
- Event
- Event 67098
- Status
- Terminated
- Classification
- Class II
- Quantity
- 268,500 products
- Official record key
device-enforcement:Z-0772-2014
Official wording
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.
Code information: Marketing Status: Class II, 510K # K011858 Device Listing Number: D043644 Lot number 3021392
Distribution pattern: Worldwide Distribution - USA (nationwide) and Internationally to Canada and Japan.
Derived failure modes
-
Unknown
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.