FDAClass IIApril 2, 2025

Baxter NovumIQ Syringe INFUSION SYSTEM recall

Baxter NovumIQ Syringe INFUSION SYSTEM , REF 40800BAXUS

Why was Baxter NovumIQ Syringe INFUSION SYSTEM recalled?

Baxter Healthcare Corporation is issuing an Urgent Medical Device Recall for the Novum IQ syringe pumps listed below due to an incorrectly installed gasket. A gasket failure could lead to potential fluid ingress due to cleaning, or as a result of an IV fluid spill.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

UDI/DI 05413765852428, Serial Numbers: 02A220600103, 02A221100387, 02A240800201, 02A230300471, 02A240800161, 02A220600112, 02A230100474, 02A240800343, 02A230400357, 02A240800175, 02A220700259, 02A230200471, 02A240800710, 02A230600165, 02A240800223, 02A220700176, 02A230200487, 02A240900081, 02A230600175, 02A240800513, 02A220700349, 02A230300030, 02A240900133, 02A230600176, 02A240800577, 02A220700268, 02A230300117, 02A240900265, 02A230600255, 02A240900261, 02A220700081, 02A230300125, 02A240900277, 02A230600256, 02A240900421, 02A220700140, 02A230300132, 02A240900285, 02A230600618, 02A240900742, 02A220700351, 02A230300146, 02A240900287, 02A230700137, 02A240900746, 02A220700409, 02A230300275, 02A240900282, 02A241000576, 02A240901067, 02A220700368, 02A230300287, 02A240900373, 02A220700166, 02A240901181, 02A220700428, 02A230300309, 02A240900407, 02A221000108, 02A240901422, 02A220700450, 02A230300350, 02A240900422, 02A221000346, 02A240901428, 02A220700454, 02A230300389, 02A240900423, 02A221000349, 02A240901430, 02A220700458, 02A230300477, 02A240900443, 02A221100154, 02A241000027, 02A220800010, 02A230300520, 02A240900427, 02A221100208, 02A241000051, 02A220800060, 02A230300547, 02A240900502, 02A221100201, 02A241000251, 02A220800201, 02A230400035, 02A240900681, 02A230200462, 02A241000254, 02A220800407, 02A230400145, 02A240900677, 02A230200495, 02A241000366, 02A221000109, 02A230600421, 02A240900749, 02A230300091, 02A241000479, 02A221000233, 02A230600549, 02A240900811, 02A230300342, 02A241000862, 02A221000240, 02A230600792, 02A240900981, 02A230300367, 02A241001284, 02A221000360, 02A230600820, 02A240901095, 02A230300417, 02A241001392, 02A221000099, 02A230600894, 02A240901196, 02A230300533, 02A241001413, 02A221100056, 02A230600908, 02A240901243, 02A230400030, 02A241001478, 02A221100116, 02A230700053, 02A241000498, 02A230600496, 02A241001496, 02A221100244, 02A230700043, 02A241000939, 02A240800026, 02A241100021, 02A221100260, 02A240600468, 02A241000957, 02A240800050, 02A241100037, 02A221100294, 02A240800006, 02A230300466, 02A240800069, 02A241100047, 02A221100346, 02A240800007, 02A230300467, 02A240800142.

Product
Baxter NovumIQ Syringe INFUSION SYSTEM , REF 40800BAXUS
Recalling firm
Baxter Healthcare Corporation
Quantity
149 units
Distribution
US Nationwide distribution in the states of AR, CA, FL, IA, IN, LA, MO, MT, NC, NY, OH, OR, PA, TN, TX, VA, WA, WI, WV.
Recall date
April 2, 2025
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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