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
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12334403
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12334652
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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
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