Z-1509-2021 Class II Terminated
FDA device recall Z-1509-2021 was initiated by B. Braun Medical, Inc. on March 15, 2021 and is designated Class II. Reason for recall: BBMI has identified through complaints the potential for the extension set to become occluded or unable to prime. The recall status is terminated (terminated June 7, 2022). Affected quantity: 1,900 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 5, 2021
- Initiation Date
- March 15, 2021
- Termination Date
- June 7, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,900 units
Product Description
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.
Reason for Recall
BBMI has identified through complaints the potential for the extension set to become occluded or unable to prime.
Distribution Pattern
US Nationwide distribution in the states of NC, CA.
Code Information
Lot #: 00SL713784, 0061741483, 0061755034, 0061755296