1) ARROWg+ard Blue MAC Two-Lumen Central Venous Access recall: Sterility Concern
1) ARROWg+ard Blue MAC Two-Lumen Central Venous Access Kit 2) ARROWg+ard Blue PSI Kit 3) ARROWg+ard Blue MAC Two-Lumen Central Venous Access Kit 4)…
Why was 1) ARROWg+ard Blue MAC Two-Lumen Central Venous Access 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: CDA-21242-1A, CDA-29803-1A, CDC-21242-1A, CDC-29803-1A, CDC-29903-1A Device Listing D025768
- Product
- 1) ARROWg+ard Blue MAC Two-Lumen Central Venous Access Kit 2) ARROWg+ard Blue PSI Kit 3) ARROWg+ard Blue MAC Two-Lumen Central Venous Access Kit 4)…
- Recalling firm
- Arrow International Inc
- Quantity
- 27,485 untis 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)