Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported October 12, 2022
Introcan Safety FEP 14G, 2.2x32MM-US, Product Code 4251890-02. A passive anti-needle device to provide venous or arterial access.
Potential for leakage at the catheter hub.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
B Braun Medical Inc recalled Introcan Safety FEP 14G, 2.2x32MM-US, Product Code 4251890-02. A passive anti-needle dev… - a moderate-severity action.
Introcan Safety FEP 14G, 2.2x32MM-US, Product Code 4251890-02. A passive anti-needle dev… was recalled by B Braun Medical Inc in October 12, 2022. Reason: Potential for leakage at the catheter hub.. Check the official notice for the remedy. Verify recall #Z-0009-2023 with the FDA Devices before acting.
The recall
B Braun Medical Inc issued this moderate-severity FDA Devices recall-Potential for leakage at the catheter hub..
- Moderate
- severity level
- Class II
- classification
- October 12, 2022
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0009-2023 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0009-2023) was formally reported on October 12, 2022, with the manufacturer initiating the action on September 1, 2022. It is classified under Moderate severity (Class II), with a current status of Ongoing. B Braun Medical Inc is listed as the recalling firm, operating out of Breinigsville, PA. Federal records list the affected scope as 94,000 US.
The documented reason for this recall is: Potential for leakage at the catheter hub. Distribution data in the federal record shows the product reached: Domestic distribution to AZ CA FL GA MD MI MO MS NC NY OH PA TN TX WA. Foreign distribution to Canada. 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
94,000 US
Related Recalls
6
3 from same agency
Product description
Introcan Safety FEP 14G, 2.2x32MM-US, Product Code 4251890-02. A passive anti-needle device to provide venous or arterial access.
Reason for recall
Potential for leakage at the catheter hub.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-0009-2023 |
| Date reported | October 12, 2022 |
| Date initiated | September 1, 2022 |
| Recalling firm | B Braun Medical Inc |
| Firm location | Breinigsville, PA |
| Affected scope | 94,000 US |
| Distribution | Domestic distribution to AZ CA FL GA MD MI MO MS NC NY OH PA TN TX WA. Foreign distribution to Canada |
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-0009-2023) 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? ▼
Introcan Safety FEP 14G, 2.2x32MM-US, Product Code 4251890-02. A passive anti-needle device to provide venous or arterial access.. Recalled by B Braun Medical Inc. Units affected: 94,000 US.
Why was this product recalled? ▼
Potential for leakage at the catheter hub.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 12, 2022. Severity: Moderate. Recall number: Z-0009-2023.
Where was the recalled product distributed? ▼
Distribution: Domestic distribution to AZ CA FL GA MD MI MO MS NC NY OH PA TN TX WA. Foreign distribution to Canada.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0009-2023) 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 October 12, 2022. 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.