Terminated

PET Infusion Pump

FDA Recall Z-0400-2017 · Posted 2016-11-11

Recalling FirmBayer Healthcare

Recall StatusTerminated

Product CodeFRN

Date Initiated2016-09-30

Date Terminated2017-03-24

Product Quantity165,127 (79,714 units in U.S.)

Reason for Recall

The Source Administration Sets (SAS) used with the Medrad Intego PET Infusion System do not meet pressure testing specifications in an occlusion situation when the product is more than one year past manufacturing date.

Firm Action

Bayer mailed an Urgent Medical Device Customer Notification letter to the affected consignees on September 30, 2016 asking that they review their current SAS inventory and determine if you have any product that is more than one year past its manufacturing date, Quarantine unused units and call Bayer Customer Care line to receive a Return Goods Authorization (RGA) number for the product's return.

Root Cause

Process control

Distribution Pattern

Distributed Nationwide and internationally to : Taiwan, Ukraine, Turkey, Thailand, Slovania, Singapore, Sweden, Saudi Arabia, Serbia, Romania, Qatar, Portugal, Poland, Panama, Oman, Norway, The Netherlands, Mexico, Malta, Morraco, Libyan, Lithuania, Lebanon, Kuwait, Italy, Israel, Hungray, United Kingdom, France, Finland, Spain, Denmark, Germany, Czech Republic, Chile, Switzerland, Belguim, Bosnia, Austria, Australia,

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K100798MEDRAD INTEGO PET INFUSION SYSTEM, SOURCE ADMINISTRATION SET, PATIENT ADMINSTRATIN SET MODEL INT SYS 100, INT CSS, INT CMedrad, Inc. · 2010-06-23 K080297MEDRAD INTEGO PET INFUSION SYSTEMMedrad, Inc. · 2008-06-17

Official Source

View FDA Recall →

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