Z-1542-2020 Class II Terminated
FDA device recall Z-1542-2020 was initiated by T.A.G. MEDICAL PRODUCTS CORPORATION, LTD. on January 20, 2020 and is designated Class II. 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. The recall status is terminated (terminated April 21, 2025). Affected quantity: 6625 units.
Recall Details
- Product Type
- Devices
- Report Date
- April 1, 2020
- Initiation Date
- January 20, 2020
- Termination Date
- April 21, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6625 units
Product Description
FlipCutter III Drill
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 Pattern
Product distributed throughout the United States, Austria, Australia, Bermuda, Switzerland, China, Germany, Denmark, France, Great Britain, Italy, Netherlands, Poland, Sweden and Taiwan.
Code Information
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