FlipCutter III Drill
Check against the official notice below — it lists the full affected range.
T.A.G. Medical Products Corporation, Ltd. is recalling 6,625 units of the FlipCutter III Drill due to a potential defect in the blister tray packaging. The cracked blister trays may compromise the sterile barrier and allow particulate matter to enter the packaging. The affected product, identified by Part Number AR-1204FF and UDI 10818674021446, was distributed across multiple countries including the United States, Austria, Australia, China, France, Germany, Great Britain, Italy, and several others. The recall affects numerous lot numbers ranging from 19E01 through 19R07.
The recall record does not specify a remedy or corrective action for consumers who have obtained this product.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
Reason for recall: 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. Distribution: Product distributed throughout the United States, Austria, Australia, Bermuda, Switzerland, China, Germany, Denmark, France, Great Britain, Italy, Netherlands, Poland, Sweden and Taiwan. Quantity: 6625 units Lot/code info: 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
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.