T.A.G. Medical Recalls FlipCutter III Drills Due to Sterile Barrier Risk
T.A.G. Medical Products is recalling 6,625 FlipCutter III Drills because cracked blister trays may compromise the sterile barrier, posing a risk of particulate contamination.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text describes a potential defect without reporting any specific illnesses, injuries, or hospitalizations, aligning with the criteria for a moderate severity precautionary recall.
Plain-English summary
T.A.G. Medical Products Corporation, Ltd. is recalling 6,625 units of the FlipCutter III Drill. The recall is due to a potential defect where the blister tray may be cracked, which could compromise the sterile barrier and allow particulate matter to enter the sterile field.
The affected product is identified by UDI 10818674021446 and Part Number AR-1204FF. The recall includes specific lots ranging from 19E01 to 19R07. The product was distributed throughout the United States and in several international locations, including Austria, Australia, Bermuda, Switzerland, China, Germany, Denmark, France, Great Britain, Italy, Netherlands, Poland, Sweden, and Taiwan.
Healthcare providers and consumers should stop using the affected FlipCutter III Drills and contact T.A.G. Medical Products Corporation, Ltd. for instructions on return or replacement.
The recalled product
- Product
- FlipCutter III Drill
- Manufacturer
- T.A.G. MEDICAL PRODUCTS CORPORATION, LTD.
- Affected units
- 6,625
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
Distribution scope not specified by the agency.
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