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Terminated

Gambro Prisma M100 preset, Part No. 8353486.

FDA Recall Z-0705-06 · Posted 2006-04-05

Recalling FirmGambro Renal Products, Inc.
Recall StatusTerminated
Product CodeKDI
Date Initiated2005-10-24
Date Terminated2012-04-17
Product Quantity28277 units

Reason for Recall

After dialysis machine is disconnected from the patient, blood leakage may occur while unloading the tubing sets from the machine.

Firm Action

Recall information was forwarded to all Gambro Sale Organizations. Notification was sent to all US consignees on November 2nd and November 3rd, 2005.

Root Cause

Other

Distribution Pattern

Nationwide, including VA facilities in AZ, CA, DC, FL, GA, MI, MO, NJ, NY, OH, OR, PA, PR, TX, UT, VA, WI. Military distribution to CA and TX. Foreign distribution to Australia, Canada, Denmark, France, Germany, Hungary, UK.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K032431PRISMA M60/M100 SETSGambro, Inc. · 2003-09-15K980386HOSPAL MULTIFLOW 100, MULTIFLOW 100 KITS A0 (A0,A0/B AND A0/0), MULTIFLOW 100 KITS B22 (B22,B22/B, & B22/0)Gambro Healthcare · 1999-02-24K981681PRISMA CFM (CONTINUOUS FLUID MANAGEMENT SYSTEM)Gambro Healthcare · 1998-08-11

Official Source

View FDA Recall →

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

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