FDAClass IIJune 14, 2017

ARROWg+ard Blue MAC Two-Lumen Central Venous Access Kit recall

ARROWg+ard Blue MAC Two-Lumen Central Venous Access Kit The MAC(TM) Multi-Lumen Central Venous Access Device with ARROWg+ard Blue(R) permits venous…

Why was ARROWg+ard Blue MAC Two-Lumen Central Venous Access Kit recalled?

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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

510K # K011761 and Material numbers CDA-21242-1A, CDA-29803-1A, and CDA-29903-1A

Product
ARROWg+ard Blue MAC Two-Lumen Central Venous Access Kit The MAC(TM) Multi-Lumen Central Venous Access Device with ARROWg+ard Blue(R) permits venous…
Recalling firm
Arrow International Inc
Quantity
unknown-firm reports total devices distributed 43,394 eaches
Distribution
Nationwide Distribution
Recall date
June 14, 2017
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls