MAC(TM) Two-Lumen Central Venous Access Kit with recall
MAC(TM) Two-Lumen Central Venous Access Kit with ARROWg+ard Blue(R) Access Device, Integral Hemostasis Valve, Sharps Safety Features and Maximal…
Why was MAC(TM) Two-Lumen Central Venous Access Kit with 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 # K002507; Material number: ASK-21142-HF2
- Product
- MAC(TM) Two-Lumen Central Venous Access Kit with ARROWg+ard Blue(R) Access Device, Integral Hemostasis Valve, Sharps Safety Features and Maximal…
- 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)