Device product
Cook Spectrum Minocycline/Rifampin Impregnated Double Lumen Central Venous Catheter Tray Cook Spectrum Minocycline/Rifampin Impregnated Triple Lumen Central Venous Catheter Tray
Z-0733-2017
Product summary
- Firm
- Cook Inc.
- Event
- Event 75793
- Status
- Terminated
- Classification
- Class II
- Quantity
- 99 units
- Official record key
device-enforcement:Z-0733-2017
Official wording
Reason: Cook Medical has received reports of the trays containing the incorrect needle, which in some cases could result in the inability to pass a wire guide through the needle. Potential adverse events that may occur as a result of utilizing needles of incorrect size include delay in treatment, which could be critical in an emergent situation. There have been no reports of illness or injury associated with this issue.
Code information: catalog number: C-UDLMY-401J-ABRM-HC-FST Lot 6498570 catalog number: C-UTLMY-501J-ABRM-HC-FST Lot 6501835 Exp date 9/30/2018
Distribution pattern: AZ CA DC GA IL LA MN MS NC NV NY OK PA TN TX WI
Derived failure modes
-
Unknown
Cook Medical has received reports of the trays containing the incorrect needle, which in some cases could result in the inability to pass a wire guide through the needle. Potential adverse events that may occur as a result of utilizing needles of incorrect size include delay in treatment, which could be critical in an emergent situation. There have been no reports of illness or injury associated with this issue.