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Recall Observatory FDA recall evidence

Device product

ARROWg+ard Blue Large-Bore Multi-Lumen CVC Kit. The large-bore multiple-lumen catheter permits venous access to the central circulation for rapid fluid administration. It ma be inserted into the jugular, subclavian or femoral veins

Z-2270-2017

March 20, 2017

Class II

Product summary

Firm
Arrow International Inc
Event
Event 76937
Status
Terminated
Classification
Class II
Quantity
N/A
Official record key
device-enforcement:Z-2270-2017

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 CDA-25123-1A

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.