Z-1567-2023Class I

ASM Replacement Battery, Component Number SUB0000864

Name: Z-1567-2023 ASM Replacement Battery, Component Number SUB0000864
Creator: ICU Medical Inc
Published: 2023-03-22
License: https://open.fda.gov/license/

Abbott Medical / initiated 2023-03-22 / Open, Classified / root cause: supplier

FDA source

ICU Medical Inc began a recall of ASM Replacement Battery, Component Number SUB0000864 on 2023-03-22. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as supplier.

Recall record

Recall number: Z-1567-2023
Classification: Class I
Status: Open, Classified
Initiated: 2023-03-22
Posted: 2023-05-16
Recalling firm: Abbott Medical
Product: ASM Replacement Battery, Component Number SUB0000864
Product code: FRN Pump, Infusion
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.
Root cause tag: supplier
FDA root cause: Under Investigation by firm
Action: 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 [email protected] 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 [email protected].
Quantity in commerce: 9984 units
Distribution: worldwide
Product codes and lots: Lot Numbers: 6036488, 6827738, 6827739, 6827740, 8408750, 8408755, 8408757

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1567-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1565-2023	Class I	Ongoing	Voluntary: Firm initiated	2023-05-24	2023-05-16
Z-1566-2023	Class I	Ongoing	Voluntary: Firm initiated	2023-05-24	2023-05-16
Z-1567-2023	Class I	Ongoing	Voluntary: Firm initiated	2023-05-24	2023-05-16
Z-1568-2023	Class I	Ongoing	Voluntary: Firm initiated	2023-05-24	2023-05-16

Product code FRN

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)