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Terminated

Prisma M100 PRE pump infusion set. Product number 107791. Each set is packaged in a plastic pouch, 4 pouches per carton box

FDA Recall Z-2199-2014 · Posted 2014-08-13

Recalling FirmGambro Renal Products, Incorporated
Recall StatusTerminated
Product CodeKDI
Date Initiated2014-07-18
Date Terminated2015-02-05
Product Quantity401,451

Reason for Recall

Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.

Firm Action

Gambro sent an Urgent Field Safety Notice dated July 18, 2014 to all end-users. A Customer Reply Form was attached to the notice for customers to complete and return.

Root Cause

Device Design

Distribution Pattern

Worldwide Distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K032431PRISMA M60/M100 SETSGambro, Inc. · 2003-09-15

Official Source

View FDA Recall →

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

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