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U.S. Department of Health and Human Services

Class 1 Device Recall Alaris Pump Module (Bezel)

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  Class 1 Device Recall Alaris Pump Module (Bezel) see related information
Date Initiated by Firm March 26, 2021
Create Date May 10, 2021
Recall Status1 Open3, Classified
Recall Number Z-1544-2021
Recall Event ID 87657
510(K)Number K133532  
Product Classification Pump, infusion - Product Code FRN
Product Alaris Pump Module, Model 8100, serviced/repaired by Infusion Pump Repair with an impacted bezel repair part
Code Information Devices distributed between 01/15/2021 and 03/14/2021. Sale Order #/Serial #: 1599930872/ 12335834, 13617863, 13447266, 13089105, 12333728, 13616451, 13618575, 12729374; 82943/ 4122252, 4122320; 01112101A/ 12638236, 13813590, 12639090, 13744738, 9951014
Recalling Firm/
Manufacturer		 Infusion Pump Repair
18 Technology Dr Ste 133
Irvine CA 92618-2311
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
Action On 03/26/2021, Voluntary Field Safety Corrective Action notices started being mailed to customers. The firm conducted further communications via email and phone. The firm asked customers with pumps serviced with the affected bezels to return the pump module units to the recalling firm so they could swap out the affected bezels or provide a refund. The firm asked customers to immediately share this field safety corrective action notification with all necessary parties within your organization to ensure that they are also aware of this action. Also, please complete and return the Customer Response Form. Customers can contact the recalling firm at: 855-477-8866 or info@infusionpumprepair.com
Quantity in Commerce 15
Distribution California
Total Product Life Cycle TPLC 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = FRN and Original Applicant = CAREFUSION 303, INC.
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