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U.S. Department of Health and Human Services

Class 1 Device Recall Alaris Pump Module, Model 8100 (Bezel)

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 Class 1 Device Recall Alaris Pump Module, Model 8100 (Bezel)see related information
Date Initiated by FirmFebruary 26, 2021
Date PostedMay 10, 2021
Recall Status1 Terminated 3 on August 15, 2024
Recall NumberZ-1543-2021
Recall Event ID 87773
510(K)NumberK133532 
Product Classification Pump, infusion - Product Code FRN
ProductAlaris Pump Module, Model 8100, serviced/repaired by Step-Har Medical with an impacted bezel repair part
Code Information Serial Numbers: 12747983 and 9919591
Recalling Firm/
Manufacturer		 STEP-HAR MEDICAL LLC
11237 Slater Ave
Fountain Valley CA 92708-5417
Manufacturer Reason
for Recall		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.
FDA Determined
Cause 2		Component design/selection
ActionOn 02/26/2021, the one customer was notified of the recall via phone call and email. On 04/15/21, a Voluntary Field Safety Corrective Action notice were mailed. The firm asked their customer to respond so the bezel repair part could be replaced. Customers can contact the recalling firm at: 657-267-0054 or stdoan@stepharmedical.com
Quantity in Commerce2
DistributionIA
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = FRN
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