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Recall Observatory FDA recall evidence

Device product

ARROWg+ard Blue MAC Two-Lumen Central Venous Access Kit. The MAC Two-Lumen Central Venous Access Device with ARROWg+ard Blue permits venous access and catheter introduction to the central circulation

Z-2264-2017

March 20, 2017

Class II

Product summary

Firm
Arrow International Inc
Event
Event 76937
Status
Terminated
Classification
Class II
Quantity
43,394 units
Official record key
device-enforcement:Z-2264-2017

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-21242-1A

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.