FlipCutter III Drill recall: Particulate Matter
FlipCutter III Drill
Why was FlipCutter III Drill recalled?
There is potential for the blister tray to be cracked causing the sterile barrier to be compromised and potential for particulate within the sterile barrier.
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?
UDI: 10818674021446 Part Number: AR-1204FF Lots: 19E01, 19E02, 19E03, 19E05, 19E10, 19E11, 19F01, 19F02, 19F03, 19F04, 19F05, 19F06, 19F07, 19F08, 19F09, 19F10, 19J15, 19J16, 19J17, 19J18, 19J19, 19J20, 19J21, 19J22, 19J23, 19J24, 19J25, 19J26, 19J28, 19J29, 19K01, 19K02, 19K03, 19K09, 19K11, 19K12, 19M01, 19M09, 19M10, 19M11, 19M12, 19M13, 19M14, 19M15, 19M16, 19M17, 19M18, 19M21, 19M22, 19N02, 19N03, 19N05, 19N06, 19N07, 19N08, 19N09, 19N11, 19N12, 19N13, 19N14, 19P01, 19P02, 19P03, 19P04, 19P05, 19P06, 19P07, 19P08, 19P09, 19P10, 19P11, 19P12, 19P13, 19R01, 19R02, 19R04, 19R05, 19R06, 19R07
- Product
- FlipCutter III Drill
- Recalling firm
- T.A.G. MEDICAL PRODUCTS CORPORATION, LTD.
- Quantity
- 6625 units
- Distribution
- Product distributed throughout the United States, Austria, Australia, Bermuda, Switzerland, China, Germany, Denmark, France, Great Britain, Italy, Netherlands, Poland, Sweden and Taiwan.
- Recall date
- April 1, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)