Medical Device Exchange Round Fluted Bur Soft Touch recall
Medical Device Exchange Round Fluted Bur Soft Touch; 2.0mm; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 5820-10-120; EXP…
Why was Medical Device Exchange Round Fluted Bur Soft Touch 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 5820-10-120.
- Product
- Medical Device Exchange Round Fluted Bur Soft Touch; 2.0mm; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 5820-10-120; EXP…
- Recalling firm
- EXP Pharmaceutical Services Corp
- Quantity
- 3
- 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)