SIGMA Spectrum Infusion Pump, Model/Catalog Number: 35700BAX2
USSIGMA Spectrum Infusion Pump, Model/Catalog Number: 35700BAX2
Recalling Firm: Baxter Healthcare Corporation
Motif du rappel / Danger
TranslatedCertain 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.
Description du produit & Identification
TranslatedSIGMA Spectrum Infusion Pump, Model/Catalog Number: 35700BAX2
Additional Source Details
| Field | Value |
|---|---|
| City | Deerfield |
| State | IL |
| Event id | 98167 |
| Address 1 | 1 Baxter Pkwy |
| Code info | 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 211... [TRUNCATED] |
| Postal code | 60015-4625 |
| Report date | 20260128 |
| Product type | Devices |
| Product quantity | 585 units |
| Reason for recall | 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. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20251128 |
| Initial firm notification | Letter |
| Center classification date | 20260116 |
Consumer Action Protocol: What You Should Do Immediately
Safety StepsInspect the NDC code, batch number, or control number on your medicine bottle or blister packaging to confirm whether your unit is included.
Do not abruptly stop critical prescribed medication without physician advice. Contact your dispensing pharmacist immediately for a safe alternative.
Under statutory consumer protection rules, consumers are entitled to a full refund, certified replacement, or free repair kit without needing the original sales receipt.
If you suffered an injury, illness, or property damage from this product, file an official incident report with regulatory authorities (FDA Devices).
Your Legal Rights as a Consumer
Recalls are legally binding corrective safety actions overseen by statutory government bodies. Recalling entities are legally prohibited from charging consumers for official safety remedies. If a retailer or dealership refuses your recall remedy, notify the issuing regulatory agency immediately.
Frequently Asked Questions About This Recall
FAQ GuideQ1:What should I do immediately if I own or bought SIGMA Spectrum Infusion Pump, Model/Catalog Number: 35700BAX2?
Check the lot number and NDC on your prescription label. For essential medications, consult your doctor or dispensing pharmacist immediately before abruptly stopping your dose.
Q2:Can I get a full refund or free repair for this recall?
Yes. Recalling manufacturers and retail merchants are required under consumer protection regulations to offer a statutory remedy—typically a full refund, certified repair kit, or replacement unit.
Q3:Do I need my original sales receipt to claim a remedy or refund?
In most recall cases, no receipt is required. Because safety recalls are matters of public health and statutory compliance, retailers and manufacturers routinely issue refunds, store credit, or replacement kits upon presentation of the affected product or lot code.
Q4:Where can I verify official information for this safety alert?
This safety alert is aggregated directly from official regulatory agency records (FDA Devices). You can click the 'Official Agency Alert' link on this page to view the primary government notice and contact the manufacturer directly.
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Aperçu
- Entreprise responsableBaxter Healthcare Corporation
- StatusOngoing
- Niveau de risqueClass II
- DistributionUS Nationwide distribution.
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🚨 SAFETY ALERT: Baxter Healthcare Corporation - SIGMA Spectrum Infusion Pump, Model/Catalog Number: 35700BAX2 Check if your household is affected: https://therecallfile.com/fr/recalls/sigma-spectrum-infusion-pump-model-catalog-number-35700bax2/FDA-Z-1121-2026
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