Cook Medical Recalls Central Venous Catheter Trays Due to Incorrect Needles
Cook Medical is recalling 99 units of Spectrum Minocycline/Rifampin Impregnated Central Venous Catheter Trays because they may contain incorrect needles, potentially preventing wire guide passage.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product where the defect could delay critical treatment in an emergent situation, but no injuries or illnesses have been reported.
Plain-English summary
Cook Medical is recalling 99 units of Cook Spectrum Minocycline/Rifampin Impregnated Double Lumen and Triple Lumen Central Venous Catheter Trays. The recall was initiated after reports indicated that some trays contained the incorrect needle. This defect may result in the inability to pass a wire guide through the needle.
The use of needles of incorrect size could lead to a delay in treatment, which may be critical in an emergent situation. The affected products are catalog numbers C-UDLMY-401J-ABRM-HC-FST (Lot 6498570) and C-UTLMY-501J-ABRM-HC-FST (Lot 6501835), with an expiration date of 9/30/2018. The products were distributed in Arizona, California, the District of Columbia, Georgia, Illinois, Louisiana, Minnesota, Mississippi, North Carolina, Nevada, New York, Oklahoma, Pennsylvania, Tennessee, Texas, and Wisconsin.
There have been no reports of illness or injury associated with this issue. Healthcare facilities and consumers should stop using the affected trays and contact Cook Medical for further instructions.
The recalled product
- Product
- Cook Spectrum Minocycline/Rifampin Impregnated Double Lumen Central Venous Catheter Tray Cook Spectrum Minocycline/Rifampin Impregnated Triple Lumen Central Venous Catheter Tray
- Manufacturer
- Cook Inc.
- Category
- Medical Device — Catheters
- Affected units
- 99
Distribution
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