T.A.G. Medical recalls FlipCutter III Drills with specific lot numbers due to risk of blister tray cracking, which could compromise sterile barriers and allow particulate contamination.
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.
T.A.G. Medical is recalling certain FlipCutter III Drills because the blister tray might crack, potentially letting contaminants enter the sterile barrier. This could lead to infections or other complications during medical procedures.
The blister tray in the device may crack, which could compromise the sterile barrier. This might allow particles or contaminants to enter the sterile area, potentially causing infections or other complications during medical procedures.
Medical professionals using the FlipCutter III Drill for procedures are most at risk. Patients undergoing surgery or other medical treatments with this device could be affected if the blister tray cracks.
Check the product for lot numbers: 19E01 through 19R07. The device has a unique identifier (UDI) of 10818674021446 and part number AR-1204FF.
Look for lot numbers on the device: 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
FlipCutter III Drill
Lot numbers 19E01 through 19R07 (specific list provided in the recall)
Check the lot number on your device; affected lots include 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
The recall record does not specify a remedy.
We’ve drafted a message you can send T.A.G. Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1542-2020 — T.A.G. Medical T.A.G. Medical Hello, I own a T.A.G. Medical that is covered by recall Z-1542-2020 from T.A.G. Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
