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Product contains latex, but not labeled as containing latex.
Hot water may splash from the washer chamber creating a burn hazard.
Product has latex free symbol on package, yet contains latex components.
Software logic error.
Potential extended charge time anomalies
10.5 Fr. Percor STAT-DL Intra-Aortic Balloon Insertion Kit, Introducer Sheath failed water leak test during final inspection.
Label lacks professional use legend and name and address of the manufacturer.
The product units in the recalled lot were in pouches which could have incomplete seals that could lead to compromised sterility.
Lacks professional use labeling and firm name and address.
The defective device may restrict the flow of sterilant to the attached endoscope and affect the sterilization process of the scope.
The dialysis treatment may be run without the bicarbonate due to an undetected bicarbonate pump stall following a sodium change.
Tandem Hemodialysis Catheter may have splits in the catheter shaft below the extension adapter
Abnormal results are flagged as normal.