Baxter Sigma Spectrum Infusion Pump with Master Drug Library (Version 6) 35700BAXR Product Usage: The Baxter Sigma Spect
FDA device recall Z-1665-2018 · posted 2018-05-04 · Terminated
Recall details
- Recalling firm
- Baxter Healthcare Corporation
- Reason for recall
- 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.
- Action taken
- On 4/3/18, Baxter HealthCare Corporation mailed URGENT MEDICAL DEVICE CORRECTION notices and Reply Forms to customers via first class mail. Actions to be Taken by Customers: 1. Locate and discontinue use of all affected pumps at your facility. 2. Return the device to Baxter for testing. To arrange for return of affected devices, contact Baxter at 800-356-3454 between the hours of 7:00 am and 7:00 pm Eastern Time, Monday through Friday. Please have your Baxter 8-digit ship-to account number, product code, serial number, and quantity of devices to be returned ready when calling. 3. If you purchased this product directly from Baxter, complete the enclosed Baxter Customer Reply Form and return it to Baxter by faxing it to 224-270-5457 or via email to fca@baxter.com even if you do not have inventory. 4. If you purchased this product from a distributor, please note that the Baxter customer reply form is not applicable. If a reply form is provided by your distributor or wholesaler, please return it to the supplier according to their instructions. 5. If you distribute this product to other facilities or departments within your institution, please forward a copy of this communication to them. 6. If you are a dealer, wholesaler, distributor/reseller, or original equipment manufacturer (OEM) that distributed any affected product to other facilities, please notify your customers.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- FRN
- Quantity affected
- 444 units in total
- Distribution
- US Nationwide & Puerto Rico
- Date initiated
- 2018-04-03
- Date posted
- 2018-05-04
- Date terminated
- 2020-02-14
- Location
- Medina, NY
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SPECTRUM AND SPECTRUM WITH MASTER DRUG LIBRARY (K042121) | Sigma Intl. | 2004-08-26 |