1) Introducer Kit with Integral Hemostasis Valve/Side recall: Sterility Concern
1) Introducer Kit with Integral Hemostasis Valve/Side Port, Sharps Safety Features, and Maximal Barrier Precautions for use with 7.5 - 8 Fr.…
Why was 1) Introducer Kit with Integral Hemostasis Valve/Side recalled?
Arrow International is recalling the affected product because the packaging may not be completely sealed, which may compromise sterility.
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?
Material number: ASK-09803-WBH1, ASK-09903-KH, CDC-09803-1A Device Listing E433883
- Product
- 1) Introducer Kit with Integral Hemostasis Valve/Side Port, Sharps Safety Features, and Maximal Barrier Precautions for use with 7.5 - 8 Fr.…
- Recalling firm
- Arrow International Inc
- Quantity
- 27,485 units distributed in U.S, 4,371 units distributed internationally
- Distribution
- Worldwide Distribution - US (nationwide) and Canada
- Recall date
- June 21, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)