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Terminated

B. Braun Introcan Safety IV Catheters, Product codes REF 4252500-01 4252519-01 4252535-01 4252560-01 4252586-01 4251890-01 4252535-01 4252586-01 4251644-01

FDA Recall Z-0509-2021 · Posted 2020-11-30

Recalling FirmJanus Trade Group
Recall StatusTerminated
Product CodeFOZ
Date Initiated2020-03-23
Date Terminated2021-05-20
Product Quantity1365 cases (200 units/case)

Reason for Recall

Distribution of B.Braun Introcan Safety IV catheters without a 510(k) within the United States by JTG.

Firm Action

Between March 13-25, 2020, Janus Trade Group made phone contact with customers requesting to check if customers had product on hand. If customers had product on hand, they were asked to send it back to JTG for a full refund.

Root Cause

No Marketing Application

Distribution Pattern

US distribution to distributors located in CA, FL, IL, KS, NJ, NY, and TN.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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