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Terminated

Continuum MR Compatible Infusion Pump. Pump Model #3009135

FDA Recall Z-0841-05 · Posted 2005-05-13

Recalling FirmMedrad Inc
Recall StatusTerminated
Product CodeFRN
Date Initiated2005-03-22
Date Terminated2005-08-17
Product Quantity461 units

Reason for Recall

Customer complaint that a continuum infusion pump was attracted to an MR scanner due to customer not completely engaging the pump into the bracket.

Firm Action

The recalling firm issued a Field Correction letter dated 3/9/05 to all their customers. The letter instructed the consignee on how to apply the new warning labels, to discard the old Operation Manual and replace it with the new one.

Root Cause

Other

Distribution Pattern

The products were shipped nationwide to hospitals and outpatient MRI office. The product was shipped to government facilities in CA, DC, MD, NJ, SC, WA, and WV. The product was also shipped to Austriala, Canada, Mexico, United Arib, Austria, Germany, Denmark, France, Great Britain, Hong Kong, Iceland, Italy, Netherlands, Norway, Portugal, Sweden, and Singapore.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K032771MEDRAD CONTINUUM MR INFUSION SYSTEMMedrad, Inc. · 2003-09-23K021988MEDRAD CONTINUUM MR COMPATIBLE INFUSION SYSTEMMedrad, Inc. · 2002-08-29

Official Source

View FDA Recall →

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

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