—#203396

Product

TERUMO 60" TUBE SET W/HIGH CRACK CHK VLV, Article No. 7S3070. Singapore only. IV injection set.

FDA product code: FPA — Set, Administration, Intravascular
Device class: Class 2
Medical specialty: General Hospital
Affected lot / code info: UDI-DI: N/A Lots 0061753485

Why it was recalled

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.

Root cause (FDA determination)

Process control

Action the firm took

On September 26, 2023, the firm notified customers via Urgent Product Recall Notification letters. Customers were informed of the potential for leakage at the male Luer lock site. Customers were instructed to report total amount of impacted product on hand to the firm, after which B Braun Customer Support will contact the customer with instructions on how to return the product for credit or replacement depending on the customer's need. Questions about this recall may be reported to BBMI s Postmarket Surveillance Department by calling 1-833-425-1464.

Recalling firm

Firm: B. Braun Medical, Inc.
Address: 901 Marcon Blvd, Allentown, Pennsylvania 18109-9512

Distribution

Distribution pattern: Worldwide distribution - US Nationwide and the countries of Canada and Singapore.

Timeline

Recall initiated: 2023-09-26
Posted by FDA: 2023-11-03
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #203396. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.