| Class 1 Device Recall Alaris Pump Module, Model 8100 (Bezel) | |
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
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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
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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.
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Quantity in Commerce | 22 units |
Distribution | Us distribution to the states of IN and TX. |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = FRN
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