Device product
Filtered Triple-Leg Extension Set - Intravascular administration set. Product Catalog number: 477034 - Product Usage: The extension set is a sterile, single-use intravascular direct injection, intermittent infusion, continuous infusion or aspiration of fluids and medications.
Z-1509-2021
Product summary
- Event
- Event 87585
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,900 units
- Official record key
device-enforcement:Z-1509-2021
Official wording
Reason: BBMI has identified through complaints the potential for the extension set to become occluded or unable to prime.
Code information: Lot #: 00SL713784, 0061741483, 0061755034, 0061755296
Distribution pattern: US Nationwide distribution in the states of NC, CA.
Derived failure modes
-
Unknown
BBMI has identified through complaints the potential for the extension set to become occluded or unable to prime.