FDA Device Recall Z-0123-2024

B. Braun Medical, Inc. · Allentown, PA

Class I — life-threatening Ongoing

Highest impact — Class I device recall — FDA determination that use of, or exposure to, the device will cause serious adverse health consequences or death. Distribution is nationwide and the recall remains in progress.

Device

8713051U, Infusomat Large Volume Pump, Wireless; Volumetric Infusion Pump System

Lot / serial / GTIN: UDI-DI: 04046964660887 Serial Numbers: 868497 -892669 ***Updated 8/7/24*** SNs added: 430056, 430119, 430155, 430243, 551518, 685947, 703196, 705968, 726936, 737729, 753364, 774163, 790843, 814074

Quantity: 9771

Reason for recall

Upstream occlusion alarm may sound when no occlusion exists, and the device will stop pumping. Interruption to the infusion of high-risk medications may lead to hemodynamic instability requiring medical intervention to prevent permanent impairment to body structures or body functions. In some cases, this may be life-threatening or may lead to death.

Recall record

Recall number: Z-0123-2024
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Domestic distribution nationwide. Foreign distribution to Canada.
Recall initiated: 2023-09-21
Classified by FDA Center: 2023-10-25
FDA published: 2023-11-01
Recalling firm: B. Braun Medical, Inc.
Firm location: Allentown, PA

Operational response

A Class I device recall indicates a strong likelihood of serious adverse health consequence or death from continued use. Identify affected units by serial number, lot, or GTIN against your inventory and against implanted-device patient registry. Pull affected inventory from active use immediately. For implanted devices, follow the recalling firm’s patient-notification protocol; in most cases this requires informing affected patients and their treating physicians directly.

For the official FDA enforcement record, see FDA's Recall Search.

‹ All device recalls