510(k) K063696 ยท FRN Pump, Infusion
COLLEAGUE VOLUMETRIC INFUSION PUMP MODEL# 2M8151,8153,8161,8163,9161,9163
| Applicant | Baxterhealthcare, Inc., Deerfield Lake IL, US |
| Decision | Substantially Equivalent, Feb 27, 2007 |
| Received | Dec 13, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K063696
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 13, 2012 | Baxter Healthcare Corp. Baxter Colleague CX Infusion Pump, Single Channel Volumetric Infusion Pumps. Baxter Healthcare Corporation, Medication Delivery Division, Deerfield, IL 60015. Product Code: 2M8161. Product Usage: Inte Terminated |
FRN | None listed |
| Jan 13, 2012 | Baxter Healthcare Corp. Baxter Colleague 3 Triple Channel Volumetric Infusion Pump. Baxter Healthcare Corporation, Medication Delivery Division, Deerfield, IL 60015. Product Code: 2M8153. Product Usage: Intended for use in a Terminated |
FRN | None listed |
| Jan 11, 2012 | Baxter Healthcare Corp. Baxter Colleague CX Infusion Pump, Single Channel Volumetric Infusion Pumps. Product Code: 2M8161. Terminated |
FRN | None listed |
| Aug 11, 2011 | Baxter Healthcare Corp. Baxter Colleague CX Infusion Pump, Single Channel Volumetric Infusion Pumps. Baxter Healthcare Corporation, Deerfield, IL; product code 2M8161 Terminated |
FRN | None listed |
| Aug 11, 2011 | Baxter Healthcare Corp. Baxter Colleague CX Infusion Pump, Single Channel Volumetric Infusion Pump. Baxter Healthcare Corporation, Deerfield, IL. Product Code: 2M8161.
Intended for use in a wide variety of patient environm Terminated |
FRN | None listed |
| Aug 8, 2011 | Baxter Healthcare Corp. Baxter Colleague CX Infusion Pump, Single Channel Volumetric Infusion Pumps. Baxter Healthcare Corporation, Medication Delivery Division, Deerfield, IL 60015. Product Code: 2M8161.
Product Usage: I Terminated |
FRN | None listed |
| Jul 19, 2011 | Baxter Healthcare Corp. Baxter Colleague CX Infusion Pump, Single Channel Volumetric Infusion Pumps. Baxter Healthcare Corporation, Medication Delivery Division. Product Code: 2M8161.
Product Usage: Intended for use in a Terminated |
FRN | None listed |
| Jul 13, 2011 | Baxter Healthcare Corp. Baxter Colleague 3 and 3 CX Infusion Pumps, Triple Channel Volumetric Infusion Pumps. Baxter Healthcare Corporation, Medication Delivery Division. Product Codes: 2 M8153 and 2M8163.
Intended for use Terminated |
FRN | None listed |
| May 19, 2011 | Baxter Healthcare Corp. Baxter Colleague, Colleague CX and Colleague CXE Infusion Pumps, Single Channel Volumetric Infusion Pumps. Baxter Healthcare Corporation, Medication Delivery Division. Product Codes: 2M8151, 2M8161 an Terminated |
FRN | None listed |
| Jan 21, 2011 | Baxter Healthcare Corp. Baxter Colleague Single Channel Volumetric Infusion Pump. Baxter Healthcare Corporation, Medication Delivery Division. Product Code: 2M8161 Terminated |
FRN | None listed |
| Jan 21, 2011 | Baxter Healthcare Corp. Baxter Colleague CX and CXE Infusion Pumps, Single Channel Volumetric Infusion Pumps. Baxter Healthcare Corporation, Medication Delivery Division. Product Codes: 2M8161 and 2M9161.
Intended for use i Terminated |
FRN | None listed |
| Oct 12, 2010 | Baxter Healthcare Corp. Baxter Colleague Single Channel Volumetric Infusion Pumps. Baxter Healthcare Corporation, Medication Delivery Division. Product Codes: 2M8151, 2M8161, and 2M9161. Terminated |
FRN | None listed |
| Oct 12, 2010 | Baxter Healthcare Corp. Baxter Colleague Triple Channel Volumetric Infusion Pumps. Baxter Healthcare Corporation, Medication Delivery Division. Product codes: 2M8153, and 2M8163. Terminated |
FRN | None listed |
| Mar 2, 2009 | Baxter Healthcare Corp. 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, 2M8161, Terminated |
FRN | None listed |
| Mar 2, 2009 | Baxter Healthcare Corp. Baxter Colleague Triple Channel Volumetric Infusion Pumps. Baxter Healthcare Corporation, Medication Delivery Division, Deerfield, IL 60015 U.S.A., Made in Singapore. Product codes: 2M8153, 2M8163, Terminated |
FRN | None listed |
| Sep 19, 2007 | Baxter Healthcare Corp. Baxter Colleague CX Single Channel Volumetric Infusion Pumps; Baxter Healthcare Corporation, Medication Delivery Division, Deerfield, IL 60015 U.S.A., Made in Singapore; product code 2M8161 Terminated |
FRN | None listed |
| Jul 28, 2007 | Baxter Healthcare Corp. 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 and 2M8161 ( Terminated |
FRN | None listed |
| Jul 28, 2007 | Baxter Healthcare Corp. Baxter Colleague Triple Channel Volumetric Infusion Pumps; Baxter Healthcare Corporation, Medication Delivery Division, Deerfield, IL 60015 U.S.A., Made in Singapore; Product codes 2M8153 and 2M8163 ( Terminated |
FRN | None listed |
| Jul 18, 2007 | Baxter Healthcare Corp. Baxter Colleague Triple Channel Volumetric Infusion Pumps; Baxter Healthcare Corporation, Medication Delivery Division, Deerfield, IL 60015 U.S.A., Made in Singapore; product codes 2M8153, 2M8163, 2M9 Terminated |
FRN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.