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Open, Classified

Alaris Infusion Pump Module, Model 8100, serviced/repaired by The Biomed Guys, with the impacted bezel repair part, TIPA-8100-4410 / Alaris 8100 Bezel.

FDA Recall Z-1651-2021 · Posted None

Recalling FirmThe Biomed Guys
Recall StatusOpen, Classified
Product CodeFRN
Date Initiated2021-03-25
Product Quantity22 units

Reason for Recall

Bezel repair part, not by the original manufacturer, used in the service and repair of Alaris Pump Module Model 8100, may experience cracking and/or separation of the bezel posts. Separation of one or more bezel posts could lead to free flow, over infusion, under infusion, or interruption of infusion.

Firm Action

The firm notified their consignees via email 3/25/2021 and multiple phone calls 3/25/2021, 3/26/2021 & 3/30/2021. Customers where also sent empty boxes with packing material to return their affected devices for inspection and remediation.

Root Cause

Under Investigation by firm

Distribution Pattern

Us distribution to the states of IN and TX.

Official Source

View FDA Recall →

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

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