Severity
Moderate
FDA Devices recall · Reported June 14, 2017
Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow product…
Arrow International Inc recalled Femoral Arterial Line Catheterization Kit The Arrow¿ Arterial Catheterization device per… - a moderate-severity action.
Femoral Arterial Line Catheterization Kit The Arrow¿ Arterial Catheterization device per… was recalled by Arrow International Inc in June 14, 2017. Reason: Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury …. Check the official notice for the remedy. Verify recall #Z-2294-2017 with the FDA Devices before acting.
The recall
Arrow International Inc issued this moderate-severity FDA Devices recall-Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury ….
Sourced from official FDA Devices enforcement records. Verify recall #Z-2294-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Devices action (record #Z-2294-2017) was formally reported on June 14, 2017, with the manufacturer initiating the action on March 20, 2017. It is classified under Moderate severity (Class II), with a current status of Terminated. Arrow International Inc is listed as the recalling firm, operating out of Reading, PA. Federal records list the affected scope as unknown-firm reports total devices distributed 43,394.
The documented reason for this recall is: Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products. Distribution data in the federal record shows the product reached: Nationwide Distribution. 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.
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.
Severity
Moderate
Affected scope
unknown-firm reports total devices distributed 43,394
Related Recalls
6
3 from same agency
Femoral Arterial Line Catheterization Kit The Arrow¿ Arterial Catheterization device permits access to the peripheral arterial circulation or to other small vessels
Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products.
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2294-2017 |
| Date reported | June 14, 2017 |
| Date initiated | March 20, 2017 |
| Recalling firm | Arrow International Inc |
| Firm location | Reading, PA |
| Affected scope | unknown-firm reports total devices distributed 43,394 |
| Distribution | Nationwide Distribution |
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.
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.
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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 June 14, 2017. 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.