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Recall Observatory FDA recall evidence

Device product

Arterial Catheterization Kit with Maximal Barrier Precautions The Arrow¿ Arterial Catheterization device permits access to the peripheral arterial circulation or to other small vessels

Z-2299-2017

March 20, 2017

Class II

Product summary

Firm
Arrow International Inc
Event
Event 76937
Status
Terminated
Classification
Class II
Quantity
unknown-firm reports total devices distributed 43,394
Official record key
device-enforcement:Z-2299-2017

Official wording

Reason: 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.

Code information: Material number ASK-04500-BGH

Distribution pattern: Nationwide Distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.