Baxter Sigma Spectrum Infusion Pump with Master Drug recall
Baxter Sigma Spectrum Infusion Pump with Master Drug Library (Version 6) 35700BAXR Product Usage: The Baxter Sigma Spectrum Infusion Pump with master…
Why was Baxter Sigma Spectrum Infusion Pump with Master Drug recalled?
Service technician improperly documented final release testing on product, indicating that the full battery of release tests were performed when, in fact, several tests were omitted. he omitted tests include air-in-line detection at 400ml/hr and 800ml/hr and verification of upstream occlusion detection at 800ml/hr. Improper detection of air-in-line or upstream occlusion may result in serious adverse health consequences.
What should I do if I have this product?
Review the official FDA enforcement record for current 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?
Serial numbers 745365 750241 750330 752814 754975 757930 762405 763117 764490 768855 772652 773031 773134 773520 774413 778845 779430 779822 781545 782706 782985 783185 787001 793146 833195 865842 883498 883854 889556 889775 890230 891398 891421 891647 891689 901881 917897 917963 919594 919736 919837 921078 921819 924734 928406 937123 940345 940860 940949 941786 944619 966019 990542 996435 996823 997156 998126 1011229 1011544 1014955 1027799
- Product
- Baxter Sigma Spectrum Infusion Pump with Master Drug Library (Version 6) 35700BAXR Product Usage: The Baxter Sigma Spectrum Infusion Pump with master…
- Recalling firm
- Baxter Healthcare Corporation
- Quantity
- 444 units in total
- Distribution
- US Nationwide & Puerto Rico
- Recall date
- May 16, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)