Medical Device Exchange 12MM VASCULAR recall
Medical Device Exchange 12MM VASCULAR; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 9-AVP2-012; EXP (repackager), Aga Medical…
Why was Medical Device Exchange 12MM VASCULAR recalled?
EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were registered and had their own quality systems.
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?
OEM Catalog number 9-AVP2-012.
- Product
- Medical Device Exchange 12MM VASCULAR; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 9-AVP2-012; EXP (repackager), Aga Medical…
- Recalling firm
- EXP Pharmaceutical Services Corp
- Quantity
- 1
- Distribution
- Distributed in DC and the states of CO, CA, FL, TX, and AR.
- Recall date
- August 5, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)