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Recall Observatory FDA recall evidence

Device product

Arrow PICC with Chlorag+ard Technology A PICC permits venous access to the central circulation through a peripheral vein. The intended use of the VP'S Stylet and Console (VPS System) is to quickly and accurately guide market available central catheters to the desired location which is the lower third of the SVC or at the cavo-atrial junction

Z-2291-2017

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-2291-2017

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-45063-HPK1A

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.