United StatesSIGMA Spectrum Infusion Pump, Model/Catalog Number 35700BAX2 (GTIN 00085412498683), distributed nationwide in the U.S.; Baxter identified 585 units by serial number as affected. The pumps were recalled because defective low-viscosity grease may provide insufficient lubrication on the cam and motor gears, which can cause premature mechanism wear that could result in over-infusion or a free-flow situation.
What's being recalled
SIGMA Spectrum Infusion Pump, Model/Catalog Number: 35700BAX2
Recalling firm: Baxter Healthcare Corporation, Deerfield, IL, United States.
How to identify it
GTIN 00085412498683; Serial Numbers: 2119054 2135735 2132190 2154666 2154656 2096922 2107882 2115820 2116236 2123750 2124467 2142165 2145693 2146570 2135601 2150159 2019614 2030571 2064474 2065875 2007842 2077077 2110000 2139163 2152387 2090011 2150576 2006741 2090877 2091360 2115605 2136756 2145367 2145911 2144366 2147107 2005818 2036444 2040404 2064488 2054317 2064576 2065380 2064711 2055127 2066486 2065852 2065982 2041955 2081026 2023286 2088106 2089908 2089953 2090012 2096271 2106362 2114760 2114275 2116368 2116054 2117183 2118056 2112866 2136545 2139711 2142076 2161326 2112386 2127356 2161111 2003644 2042815 2089901 2026384 2157334 2004602 2093902 2134816 2155520 2156545 2107252 2136765 2152712 2027178 2135072 2081009 2145203 2156837 2124901 2077354 2077117 2122684 2118643 2106472 2145820 2009374 2115158 2090446 2125551 2150237 2004798 2013799 2023938 2092704 2148207 2096246 2007553 2014364 2089297 2089770 2089790 2119778 2105983 2088857 2140961 2119801 2075390 2013353 2014754 2115703 2105569 2106297 2108307 2107928 2107024 2094331 2010527 2108679 2133529 2133609 2091040 2105718 2138210 2106084 2062517 2022721 2106575 2106357 2106667 2026959 2105921 2098876 2106666 2104788 2106441 2020080 2106646 2106571 2020358 2102437 2106458 2106975 2104537 2026270 2021619 2104636 2105332 2106348 2106213 2019141 2023340 2106243 2100062 2106694 2106468 2106652 2106644 2106687 2104780 2106781 2105011 2105920 2105399 2106661 2106657 2104225 2101214 2020660 2106401 2014906 2104935 2105761 2106381 2106706 2105316 2105830 2102959 2106658 2105682 2128181 2108278 2152865 2139013 2109590 2106397 2105502 2105517 2089502 2085260 2055930 2062659 2031944 2115307 2125787 2151876 2152606 2126978 2163477 2140825 2115351 2037060 2121404 2125165 2093359 2021479 2136589 2156064 2126079 2125854 2011851 2021129 2144675 2127091 2133796 2110399 2106566 2096065 2096542 2127985 2105537 2110489 2106110 2105686 2106565 2105353 2106522 2105857 2111300 2112189 2115454 2102374 2114689 2112238 2106823…
The hazard
Certain pumps have potentially been released from service with defective grease applied to the cam and motor gears. Due to its low viscosity, the defective grease may lead to the device having insufficient lubrication on the cam, which could lead to premature wear of the mechanism assembly, resulting in over-infusion or a free-flow situation.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
US Nationwide distribution.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)