Recall
Medline Industries, LP: Medline Kits: 1) CATH LAB CDS, Model Number: CDS840228F; 2) IR PACK, Model Number: DYNDH2104; 3) CARDIAC CATH PACK-LF, Model Number: DYNJT21 Recall
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded. Product details: Medline Kits: 1) CATH LAB CDS, Model Number: CDS840228F; 2) IR PACK, Model Number: DYNDH2104; 3) CARDIAC CATH PACK-LF, Model Number: DYNJT2164M; 4) ANGIOGRAPHY TRAY, Model Number: DYNJT3078; 5) CATH PACK, Model Number: DYNJT4190; 6) ANGIO VASCULAR PACK, Model ...
What happened?
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded. Product details: Medline Kits: 1) CATH LAB CDS, Model Number: CDS840228F; 2) IR PACK, Model Number: DYNDH2104; 3) CARDIAC CATH PACK-LF, Model Number: DYNJT2164M; 4) ANGIOGRAPHY TRAY, Model Number: DYNJT3078; 5) CATH PACK, Model Number: DYNJT4190; 6) ANGIO VASCULAR PACK, Model ...
Who may be affected?
US Nationwide distribution.
What should consumers do?
Affected quantity: 160883 units
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