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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 Firm March 25, 2021
Create Date June 01, 2021
Recall Status1 Open3, Classified
Recall Number Z-1651-2021
Recall Event ID 87768
510(K)Number K133532  
Product Classification Pump, infusion - Product Code FRN
Product Alaris Infusion Pump Module, Model 8100, serviced/repaired by The Biomed Guys, with the impacted bezel repair part, TIPA-8100-4410 / Alaris 8100 Bezel.
Code Information Serial numbers of serviced devices, serviced 09/2020-02-2021: 12833065, 13187021, 13187811, 12838069, 12982509, 12837231, 12835186, 12837972, 12710593, 12776790, 13753893, 13605919, 12832544, 15763526, 14806203, 14806612, 14807070, 13738432, 15763547, 15865626, 14806472, 12796415,  
Recalling Firm/
Manufacturer		 The Biomed Guys
1865 Ashland City Rd Ste H
Clarksville TN 37043-6455
For Additional Information Contact Philip J. LaSalle
877-246-6330 Ext. 1
Manufacturer Reason
for Recall		 Bezel repair part, not by the original manufacturer, used in the service and repair of Alaris Pump Module Model 8100, may experience cracking and/or separation of the bezel posts. Separation of one or more bezel posts could lead to free flow, over infusion, under infusion, or interruption of infusion.
FDA Determined
Cause 2		 Under Investigation by firm
Action The firm notified their consignees via email 3/25/2021 and multiple phone calls 3/25/2021, 3/26/2021 & 3/30/2021. Customers where also sent empty boxes with packing material to return their affected devices for inspection and remediation.
Quantity in Commerce 22 units
Distribution Us distribution to the states of IN and TX.
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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