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FDADecember 22, 2017device

(1) Arterial Catheterization Kit, Part Number (PN): ASK-04018-CC; (2) Arterial Line Kit with Sharps Safety Features, PN: ASK-04510-HUM; (3) Arterial Line Kit with Sharps Safety Features, PN: ASK-04550-UHC; (4) Arterial Catheterization Kit, PN: NA-04550-X1A

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.

What to do

FDA enforcement status: Terminated

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Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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