FDA Enforcement
Class I
Terminated
Alaris Pump Module, Model 8100, serviced/repaired by Step-Har Medical with an impacted bezel repair part
Recall: Z-1543-2021
·
Reported May 19, 2021
Enforcement
- Recall Number
- Z-1543-2021
- Event ID
- 87773
- Classification
- Class I
- Status
- Terminated
- Product Type
- Devices
- Firm
- STEP-HAR MEDICAL LLC
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Report Date
- May 19, 2021
- Initiation Date
- February 26, 2021
- Classification Date
- May 10, 2021
- Termination Date
- August 15, 2024
- Address
- 11237 Slater Ave, Fountain Valley, CA, 92708-5417, United States
Description
Alaris Pump Module, Model 8100, serviced/repaired by Step-Har Medical with an impacted bezel repair part
Reason
Bezel repair parts used, not by the original manufacturer, to service and repair infusion pump modules, may over time experience cracking or separation of the posts from the bezel. The separation of one or more bezel repair part posts may result in free flow, over infusion, under infusion or interruption of infusion.
Code Info
Serial Numbers: 12747983 and 9919591
Distribution
IA
Quantity
2