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Terminated

Baxter Colleague Single Channel Volumetric Infusion Pumps; Baxter Healthcare Corporation, Medication Delivery Division, Deerfield, IL 60015 U.S.A., Made in Singapore; product codes 2M8151, 2M8151R, 2M8161, 2M8161R

FDA Recall Z-0483-2007 · Posted 2007-01-11

Recalling FirmBaxter Healthcare Corp.
Recall StatusTerminated
Product CodeFRN
Date Initiated2006-12-06
Date Terminated2011-06-30
Product Quantity267,317 pumps

Reason for Recall

Baxter has identified the potential for a corruption of the memory chip in the pump to occur due to linear accelerator radiation exposure. If corruption occurs, it could result in an interruption of therapy with an audible and visual alarm notification to the user.

Firm Action

Baxter sent the 12/6/06 Safety Alert letter to all Colleague Infusion Pump customers, to the attention of the Director of Radiation Oncology with copies to the Medical Physicist and Vice President of Nursing, via first class mail to advise them that the Colleague pump is not recommended for use in Linear Accelerator radiation therapy suites. The letters informed the users that there is a potential for a corruption of the memory chip to occur due to linear accelerator radiation exposure. If corruption occurs, it could result in an interruption of therapy with an audible and visual alarm notification to the user. The letter listed the error codes that may occur if the pump has been exposed to this type of radiation: 18:200, 18:416, 36:416, 19:113, 41:113, 314:432 and 302:435:XXXX:0006. If the pump displays any of the codes, the user was requested to submit the pump to their service facility. Failure code 199 may also occur and requires reconfiguration of the pump settings by the user's biomedical services organization. Any questions were directed to Baxter Global Technical Services at 1-800-843-7867, prompt 2.

Root Cause

Other

Distribution Pattern

Worldwide including USA, Puerto Rico, Aruba, Australia, Austria, Bahrain, Belgium, Bermuda, Brazil, Canada, Cayman, Chile, China, Colombia, Curacao, Denmark, Dominican Republic, El Salvador, Finland, France, Germany, Greece, Guatemala, Hong Kong, Honduras, Ireland, Israel, Italy, Jamaica, Korea, Kuwait, Lebanon, Macedonia, Malaysia, Malta, Mexico, Netherlands, New Zealand, Norway, Oman, Panama, Peru, Philippines, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad, Turkey, United Arab Emirates, United Kingdom and Venezuela.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K041191COLLEAGUE VOLUMETRIC INFUSION PUMPSBaxter Healthcare Corp · 2004-06-25

Official Source

View FDA Recall →

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

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