Severity
Critical
CriticalClass IOngoing
FDA Devices recall · Reported April 28, 2021
Aftermarket Alaris Infusion Pump Module Model 8100 Front Bezel, installed by Pacific Medical Group (DBA Avante Health Solutions)
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 co…
Pacific Medical Group Inc. recalled Aftermarket Alaris Infusion Pump Module Model 8100 Front Bezel, installed by Pacific Medi… - a critical-severity action.
Aftermarket Alaris Infusion Pump Module Model 8100 Front Bezel, installed by Pacific Medi… was recalled by Pacific Medical Group Inc. in April 28, 2021. Reason: Aftermarket front bezel components were installed during service/repair, not by the original manufacturer, wi…. Check the official notice for the remedy. Verify recall #Z-1375-2021 with the FDA Devices before acting.
The recall
Pacific Medical Group Inc. issued this critical-severity FDA Devices recall-Aftermarket front bezel components were installed during service/repair, not by the original manufacturer, wi….
- Critical
- severity level
- 2K units
- affected scope
- Class I
- classification
- April 28, 2021
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1375-2021 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1375-2021) was formally reported on April 28, 2021, with the manufacturer initiating the action on March 24, 2021. It is classified under Critical severity (Class I), with a current status of Ongoing. Pacific Medical Group Inc. is listed as the recalling firm, operating out of San Clemente, CA. Federal records list the affected scope as 2452.
The documented reason for this recall is: 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. Separatio… Distribution data in the federal record shows the product reached: Distribution US nationwide.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
2452
Related Recalls
6
3 from same agency
Product description
Aftermarket Alaris Infusion Pump Module Model 8100 Front Bezel, installed by Pacific Medical Group (DBA Avante Health Solutions)
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Ongoing |
| Recall number | Z-1375-2021 |
| Date reported | April 28, 2021 |
| Date initiated | March 24, 2021 |
| Recalling firm | Pacific Medical Group Inc. |
| Firm location | San Clemente, CA |
| Affected scope | 2452 |
| Distribution | Distribution US nationwide. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1375-2021) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Aftermarket Alaris Infusion Pump Module Model 8100 Front Bezel, installed by Pacific Medical Group (DBA Avante Health Solutions). Recalled by Pacific Medical Group Inc.. Units affected: 2452.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 28, 2021. Severity: Critical. Recall number: Z-1375-2021.
Where was the recalled product distributed? ▼
Distribution: Distribution US nationwide..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1375-2021) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
CPSC Moderate
Rowenta Recalls Cordless Vacuum Cleaners Due to Risk of Serious Injury from Fire and Burn Hazards
· 2026-07-02
CPSC Moderate
Daikin Comfort Technologies Manufacturing Recalls Amana Air Conditioners and Heat Pumps Due to Risk of Serious Injury f…
· 2026-06-25
CPSC Moderate
Arizer Solo III Portable Vaporizers Recalled Due to Fire and Burn Hazards; Risk of Serious Injury or Death; Imported by…
· 2026-06-18
FDA Devices Moderate
GE HealthCare TRADE IN CARESCAPE TELEMETRY SERVER ARK-2250L - NORTH AMERICA, REF #5697603-902, Product Code KSA; used i…
GE Medical Systems Information Technologies Inc · 2026-06-03
FDA Devices Critical
Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: 1) BLOCK TRAY, Medline Kit…
Medline Industries, LP · 2026-06-03
Compare this recall with Rowenta Recalls Cordless Vacuum Cleaners Due to Risk of Ser… →
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported April 28, 2021. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.