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U.S. Department of Health and Human Services

Class 1 Device Recall Tenacore serviced Alaris Pump Bezel Assembly

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  Class 1 Device Recall Tenacore serviced Alaris Pump Bezel Assembly see related information
Date Initiated by Firm February 25, 2021
Create Date April 02, 2021
Recall Status1 Open3, Classified
Recall Number Z-1332-2021
Recall Event ID 87470
510(K)Number K133532  
Product Classification Pump, infusion - Product Code FRN
Product Alaris Infusion Pump 8100 Bezel (plastic piece only), Part: TIPA-8100-4410
Code Information Parts distributed between July 10, 2020 and January 22, 2021. Time stamp at bezel rear side shows 5 or 6 SO Numbers: 271111, 263873, 264442, 264890, 268606, 269930, 270760, 270936, 271211, 272860, 267603, 268936, 269258, 269291, 272496, 272225, 271408, 267392 
Recalling Firm/
Tenacore LLC
1525 E Edinger Ave
Santa Ana CA 92705-4907
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
Under Investigation by firm
Action On 02/25/2021, Field Safety Corrective Action notifications were mailed to customers; customers were also notified via phone. The recalling firm provided the following services to customers: serviced infusion pumps, sold infusion pumps, and sold bezel repair parts. Customers were asked to do the following: 1. Review the serialized list of potentially impacted pumps and remove these devices from clinical use and immediately quarantine them until they can be inspected, and impacted parts are replaced, if necessary. Part customers were told to quarantine affected parts. 2. Inspect the potentially affected devices to determine if the impacted bezel repair part is installed. Refer to inspection instructions and a) identify the impacted Alaris 8100 Infusion Pump Module by serial number; b) Look from the top down for the ejector pin marks, c) If NO ejector pin marks are identified, this module requires bezel. Customers who were sold pumps can identify affected pumps through serial number alone. 3. Dealers and Distributors only: If potentially impacted pumps were sold, immediately identify, inspect and recall, if necessary, the potentially affected pumps. An electronic copy of a proposed field safety corrective action notice will be provided that can to be used for the facilities that may be using the potentially affected pumps. 4. Contact the recalling firm to schedule bezel repair part replacement. The impacted bezel repair part must be replaced before the pump can be returned to service. 5. Please 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. Notify end user customers. 6. Complete and return the customer response form. Contact Quality Assurance at 714-371-9919 or Quality@Tenacore.com to schedule replacement of the impacted part.
Quantity in Commerce 1494
Distribution US distribution to states of: WA, AZ, NY, TX, LA, CA, NV, ME, MN, DE, NC, FL, MO, KY, TN, and PA
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.