Baxter Healthcare Corporation recalls Baxter Spectrum IQ Infusion System with Dose IQ Safety Software
Reason for recall
There is the potential for missing motor mounting screws, which may have occurred during the servicing process.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
Affected products & lots
- Baxter Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code3570009323 affected lots30202903020992302099630219293023080302318330235373023758
+315 more
350052935027993502864351080635116393512647351480135168883517399351751735185583519053356406435648183565462356562035660223566254356714535672183567998356852735689223570910357110035715983571972357314735735043574293357503335751073576026357644336567323657316365754136578143657821365799536592593660176366024436629863664495366562437216083721910372194637226203723725372421137302703730408373230937324763734858373501037352613735734373812237442193744455374615937467493749111374992937645913767418351996935201383520706352074635208293521120352133836060993607097360768136087303609223361066836108203611120361114036116503612298361288636130523614035361559936158163616449366644336664513667116366807636686543668851366905836691263669307367094236714443672061367284636760993677241367951136805423681596368198136867433689421369145336914963693341369626836183543619039361987636202963620427362063136206433620757362106836212523621777362391536239633624131362454636275193628177363096436320853632710363283036332673634729363479236993213699388369982236999173700350370055137017853703127370342537035133703840370405637042283705346370631137067623706856370789630021003003072300406930062543006831300911630099183011726301292930130323013567301499030151793015242301650130182803018908302020635764483576730357686735771583578268357853635787723578906358493335870773588099359069035910613591360359199735932973634941363514236374573638689364018936422003642537364272036450793645908364668036471263647441364754036478663648851364887836503553650984365137236541083655491365561836557853655938365653135218733521999352203835222533522529352378335239843524348352452235288693528966352940235296283529632352963635299283529935353035035307873531077353141935347053539485353974035402403540832359522235988093599437360101236013823602225360324036036373603686360384236038523603947360471636056403605644360599436974963697667369786436980343698139369833636990503699248354108535422133542383354280935428393543062354308335431723544259354613235483373548404354904735523923554222355497135559013555949355616835562783556819355687635571313557902356024535623243562649356270535629753616568361664836173273617431361774437081833708637370869537090273709669371018837114753714210371582437175943718985
What the firm is doing
Baxter issued an "URGENT MEDICAL DEVICE RECAL" notice to its consignees on 02/05/2025 via US Mail. The notice explained the issue, hazard involved, and requested the following actions be taken: "1. Immediately locate, isolate, and cease all use of Spectrum pumps with the affected serial numbers. The product code and serial number can be found on the bottom of the infusion pump. 2. Contact Baxter to arrange for the return of the affected pumps for inspection and reservicing as applicable. 3. If you received this communication directly from Baxter, acknowledge receipt on the enclosed reply form even if you have no remaining inventory. If you do not complete the acknowledgement, you will receive a phone call from OnProcess Technology on behalf of Baxter to confirm your receipt of this notification. 4. If you purchased this product from a distributor or wholesaler, please note that responding on the Baxter customer portal is not applicable. If a response is requested by your distributor or wholesaler, please respond to them according to their instructions. 5. Please forward a copy of this communication to all departments within your institution who use the affected product. 6. If you are a dealer, wholesaler, distributor/reseller, or original equipment manufacturer (OEM) that distributed any affected product to other facilities, please conduct a user-level recall of the affected product that you distributed to customers and check the associated box on the customer portal. For general questions regarding this communication, or quality problems, please contact your Baxter sales representative, or Baxter Global Technical Services at 800-843-7867 Monday through Friday, between 7:00 am and 7:00 pm Eastern Time."
DistributionShow detailsHide
US: Nationwide
A reasonable probability that use of the product will cause serious adverse health consequences or death.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-1254-2025
- FDA 510(k) clearance · K230041The device's official FDA premarket clearance record
- FDA device classification · FRNOfficial FDA classification for this device type
- CFR regulation · 21 CFR 880.5725The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Baxter Healthcare CorporationSearch for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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