Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported December 30, 2020
APEX Compounding System Control Panel Module, REF: 601224, Product Code AX1000 - Product Usage: intended for intravascular administration to a patient.
There is the potential for the compounding system to not immediately interrupt compounding and alert user to the presence of an air bubble exceeding 3% of the ordered volume for a…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
B Braun Medical, Inc. recalled APEX Compounding System Control Panel Module, REF: 601224, Product Code AX1000 - Product … - a moderate-severity action.
APEX Compounding System Control Panel Module, REF: 601224, Product Code AX1000 - Product … was recalled by B Braun Medical, Inc. in December 30, 2020. Reason: There is the potential for the compounding system to not immediately interrupt compounding and alert user to …. Check the official notice for the remedy. Verify recall #Z-0717-2021 with the FDA Devices before acting.
The recall
B Braun Medical, Inc. issued this moderate-severity FDA Devices recall-There is the potential for the compounding system to not immediately interrupt compounding and alert user to ….
- Moderate
- severity level
- 248 units
- affected scope
- Class II
- classification
- December 30, 2020
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0717-2021 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0717-2021) was formally reported on December 30, 2020, with the manufacturer initiating the action on November 23, 2020. It is classified under Moderate severity (Class II), with a current status of Terminated. B Braun Medical, Inc. is listed as the recalling firm, operating out of Carrollton, TX. Federal records list the affected scope as 248 units.
The documented reason for this recall is: There is the potential for the compounding system to not immediately interrupt compounding and alert user to the presence of an air bubble exceeding 3% of the ordered volume for an ingredient. This could result in a a… Distribution data in the federal record shows the product reached: US Nationwide distribution including in the states of AL, AZ, CA, CO, CT, FL, GA, IA, IL, LA, MA, MD, MI, MN, MO, NC, NH, NJ, NV, NY, OH, OK, PA, TN,TX, WA.. 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 moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
248 units
Related Recalls
6
3 from same agency
Product description
APEX Compounding System Control Panel Module, REF: 601224, Product Code AX1000 - Product Usage: intended for intravascular administration to a patient.
Reason for recall
There is the potential for the compounding system to not immediately interrupt compounding and alert user to the presence of an air bubble exceeding 3% of the ordered volume for an ingredient. This could result in a a compounded drug that does not meet the specified accuracy range for an individual ingredient.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0717-2021 |
| Date reported | December 30, 2020 |
| Date initiated | November 23, 2020 |
| Recalling firm | B Braun Medical, Inc. |
| Firm location | Carrollton, TX |
| Affected scope | 248 units |
| Distribution | US Nationwide distribution including in the states of AL, AZ, CA, CO, CT, FL, GA, IA, IL, LA, MA, MD, MI, MN, MO, NC, NH, NJ, NV, NY, OH, OK, PA, TN,TX, WA. |
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-0717-2021) 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.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. 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? ▼
APEX Compounding System Control Panel Module, REF: 601224, Product Code AX1000 - Product Usage: intended for intravascular administration to a patient.. Recalled by B Braun Medical, Inc.. Units affected: 248 units.
Why was this product recalled? ▼
There is the potential for the compounding system to not immediately interrupt compounding and alert user to the presence of an air bubble exceeding 3% of the ordered volume for an ingredient. This could result in a a compounded drug that does not meet the specified accuracy range for an individual ingredient.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 30, 2020. Severity: Moderate. Recall number: Z-0717-2021.
Where was the recalled product distributed? ▼
Distribution: US Nationwide distribution including in the states of AL, AZ, CA, CO, CT, FL, GA, IA, IL, LA, MA, MD, MI, MN, MO, NC, NH, NJ, NV, NY, OH, OK, PA, TN,TX, WA..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0717-2021) 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.
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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 December 30, 2020. 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.