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U.S. Department of Health and Human Services

Class 1 Device Recall Alaris Pump, installed by Pacific Medical Group (DBA Avante Health Solutions)

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  Class 1 Device Recall Alaris Pump, installed by Pacific Medical Group (DBA Avante Health Solutions) see related information
Date Initiated by Firm March 24, 2021
Create Date April 19, 2021
Recall Status1 Open3, Classified
Recall Number Z-1375-2021
Recall Event ID 87483
510(K)Number K133532  
Product Classification Pump, infusion - Product Code FRN
Product Aftermarket Alaris Infusion Pump Module Model 8100 Front Bezel, installed by Pacific Medical Group (DBA Avante Health Solutions)
Code Information Serial Numbers of devices serviced/purchased 07/10/2020-02/18/2021: 4105026 4122780 9925856 9961244 12333241 12333419 12333802 12334211 12334212 12334213 12334214 12334319 12334403 12334424 12334452 12334652 12334713 12334833 12334896 12334950 12334951 12334957 12335116 12335128 12335147 12335159 12335163 12335212 12335232 12335260 12335304 12335380 12335427 12335481 12335513 12335522 12335570 12335596 12335606 12335625 12335642 12335673 12335722 12335754 12335790 12335792 12335883 12335904 12335921 12335926 12335967 12335970 12336005 12336011 12336156 12336165 12336273 12336275 12336279 12336280 12336293 12336305 12336395 12336402 12336403 12336430 12336435 12336461 12336630 12336668 12336694 12336971 12337823 12421700 12517224 12524554 12524783 12544522 12568207 12570110 12570217 12571055 12580490 12586058 12586274 12586333 12587144 12588342 12590617 12590762 12591783 12591900 12592059 12592353 12592442 12592545 12592622 12592624 12592771 12592840 12592879 12592944 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Recalling Firm/
Manufacturer		 Pacific Medical Group Inc.
212 Avenida Fabricante
San Clemente CA 92672-7538
For Additional Information Contact
800-449-5328
Manufacturer Reason
for Recall		 Aftermarket front bezel components were installed during service/repair, not by the original manufacturer, within infusion pump modules. Over time, the posts on the front bezel component may crack or separate. Separation of one or more bezel posts could lead to free flow, over infusion, under infusion, or interruption of infusion.
FDA Determined
Cause 2		 Component design/selection
Action On 03/24/2021, Medical Device Recall Notifications were emailed to customers. Customers were asked to take the following actions: If you have affected product, remove these devices from clinical use and immediately quarantine them until the impacted parts can be returned to the recalling firm; contact Customer Service 800-449-5328, pm.recallapm@avantehs.com. The recall part number is RCL2021-823-01. Once returned, the affected device will be evaluated and inspected and where the component under recall is identified, it will be replaced by our organization with the OEM component and then returned. If your facility has used the component under recall in repairs of the top assembly immediately stop use and quarantine the affected product until the impacted parts are replaced. If you have resold/distributed the affected product, please forward this notice to your customers. Complete and submit the recall acknowledgment form to pm.recallapm@avantehs.com
Quantity in Commerce 2452
Distribution Distribution US nationwide.
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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