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Recall Observatory FDA recall evidence

Device product

Arrow Pressure Injectable PICC Kit The Arrow International Pressure Injectable PICC is intended for short-term or long-term peripheral access to the central venous system for intravenous therapy and blood sampling

Z-2256-2017

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 eaches
Official record key
device-enforcement:Z-2256-2017

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: 510K # K061289; Material numbers: EU-04041-HPMSB, EU-04052-HPMSB, EU-05041-HPMSB, and EU-05052-HPMSB.

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.