Replacement Battery List Number SUB0000864, found in Plum 360 Infusion System, List Number 30010
FDA device recall Z-1565-2023 · posted 2023-05-16 · Open, Classified
Recall details
- Recalling firm
- ICU Medical Inc
- Reason for recall
- Due to a manufacturing defect from the battery supplier, affected batteries may experience a loss of capacity earlier in the battery lifecycle than expected and overall battery runtime may decrease earlier in the battery lifecycle than expected.
- Action taken
- ICU medical issued an URGENT: MEDICAL DEVICE CORRECTION notice on 03/22/2023 to its direct and indirect consignees by mail. The notice explained the issue and the hazard and requested the following: Clinical Users: Whenever possible, keep the pump plugged into AC power. Before disconnecting the pump from AC power, please ensure that the battery is fully charged. Closely monitor the Battery Status Indicator while the pump is disconnected from AC power. Additionally, have a backup pump available when infusing critical medications. Biomedical Engineering: You may replace affected batteries with a new CSB battery until corrected batteries are available. Please do not use a replacement battery with corroded battery terminals. 1. Identify all affected batteries in your possession and ensure all users or potential users of these pumps are immediately made aware of this notification and proposed mitigations. 2. Complete and return the attached Response Form to icumedical5967@sedgwick.com within ten days of receipt to acknowledge your understanding of this notification. 3. DISTRIBUTORS: If you have distributed potentially affected products to your customers, please immediately forward this notice to them. Request that they complete the response form and return it to icumedical5967@sedgwick.com.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- FRN
- Quantity affected
- 28656 units
- Distribution
- worldwide
- Date initiated
- 2023-03-22
- Date posted
- 2023-05-16
- Location
- Lake Forest, IL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play Module (K161469) | Hospira, Inc. | 2017-03-28 |
| PLUM 360 INFUSION SYSTEM WITH HOSPIRA MEDNET, SMART CARD PLUG N PLAY CE 3.0 MODULE FOR PLUM A+ INFUSION SYSTEM UPGRADE (K141789) | Hospira, Inc. | 2015-01-16 |