FDA Enforcement
Class II
Ongoing
TERUMO 60" TUBE SET W/HIGH CRACK CHK VLV, Article No. 7S3070. Singapore only. IV injection set.
Recall: Z-0132-2024
·
Reported November 15, 2023
Enforcement
- Recall Number
- Z-0132-2024
- Event ID
- 93074
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- B. Braun Medical, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- November 15, 2023
- Initiation Date
- September 26, 2023
- Classification Date
- November 3, 2023
- Address
- 901 Marcon Blvd, Allentown, PA, 18109-9512, United States
Description
TERUMO 60" TUBE SET W/HIGH CRACK CHK VLV, Article No. 7S3070. Singapore only. IV injection set.
Reason
Devices may leak as a result of a manufacturing issue. Leakage may result in a delay of therapy, increase risk of bloodstream infection (BSI), and may expose both patients and healthcare workers to hazardous medication. There is also the potential for life-threatening situations to occur requiring additional medical intervention.
Code Info
UDI-DI: N/A Lots 0061753485
Distribution
Worldwide distribution - US Nationwide and the countries of Canada and Singapore.
Quantity
12,800 units