Baxter Sigma Spectrum Infusion System (V6 Platform), Product Code 35700BAX
Baxter Healthcare Corporation · There is the potential for missing motor mounting screws, which may have occurred during the servicing process.
Open FDA's page for this record- Cfres ID
- 212492
- Product res number
- Z-1253-2025
- Event date initiated
- 2025-02-05
- Event date posted
- 2025-03-06
- Recall status
- Open, Classified
- Res event number
- 96289
- Product code
- FRN
- Product description
- Baxter Sigma Spectrum Infusion System (V6 Platform), Product Code 35700BAX
- Firm FEI number
- 1417572
- Recalling firm
- Baxter Healthcare Corporation
- Address 1
- 1 Baxter Pkwy
- City
- Deerfield
- State
- IL
- Postal code
- 60015-4625
- Additional info contact
- Center for One Baxter 800-422-9837
- Reason for recall
- There is the potential for missing motor mounting screws, which may have occurred during the servicing process.
- Root cause description
- Under Investigation by firm
- Product quantity
- 66 units
- Distribution pattern
- US: Nationwide
- Code info
UDI/DI 00085412091570, Serial Numbers: 704198, 728888, 751492, 758399, 758614, 761662, 763197, 766291, 772611, 773302, 775486, 778837, 785425, 793453, 795240, 798065, 814485, 818850, 826637, 850214, 850854, 851500, 854157, 855803, 863354, 870307, 873114, 876483, 877014, 877102, 889153, 896292, 900181, 906422, 907176, 912242, 913562, 927864, 938265, 958176, 962828, 963975, 965158, 974676, 981605, 982459, 984154, 986132, 986634, 989053, 993087, 994417, 994842, 995538, 997153, 1006359, 1011058, 1013925, 1014064, 1014529, 1014856, 1017150, 1017546, 1018229, 1018703, 1024109
- Action
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."
- K numbers
- K133801
- Harmonized identifiers (openFDA)
- Device name
- Pump, Infusion
- Medical specialty description
- General Hospital
- Regulation number
- 880.5725
- Device class
- 2
- K number
- K052219, K922074, K983321, K032642, K101194, K091855, K880623, K850488, K931549, K791720, K944721, K801704, K003543, K864997, K011096, K844719, K890862, K915407, K822454, K891583, K961862, K042432, K910007, K812035, K921050, K896593, K090736, K871084, K932895, K990518, K800569, K124053, K883902, K043600, K994374, K865058, K214045, K823204, K895709, K913661 +809 more
- Registration number
- 1526611, 1055927, 2320968, 2027804, 3018094310, 3008058400, 3013298431, 9617594, 3003927385, 3009456923, 3005382983, 3011688490, 2029015, 3012302888, 2244478, 9617787, 1061124, 1314417, 1054713, 3004548776, 3013764800, 3010564249, 1320894, 2024022, 2523676, 9610825, 9681819, 1921846, 3007738736, 9680425, 3006534321, 9680741, 3020777588, 1018470, 3013722099, 1220973, 3000240707, 3004112621, 3009754410, 3016798778 +108 more
- FEI number
- 1526611, 3018094310, 3008058400, 3013298431, 3003927385, 1000113359, 3003282181, 1000160458, 3009456923, 3005382983, 3011688490, 3012302888, 1314417, 3004548776, 3000957797, 3000206435, 3001236905, 3013764800, 3010564249, 3002826093, 3003166194, 2648209, 1000138054, 2024022, 3003076831, 2523676, 1921846, 3000147578, 3007738736, 3006534321, 3020777588, 3002879021, 1018470, 3003767881, 3013722099, 3002807099, 3003513491, 1220973, 3000240707, 3004112621 +108 more