Cook Inc. Recalls Single Lumen Central Venous Catheter Sets
Cook Inc. is recalling 1,341 single-lumen central venous catheter sets and trays due to a manufacturing defect that may cause catheter tip fracture or separation.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall involves a structural defect in a medical device that can cause catheter tip fracture or separation, potentially leading to serious injury or the need for medical intervention to retrieve the fragment.
Plain-English summary
Cook Inc. is recalling 1,341 units of Single Lumen Central Venous Catheter Sets and Trays. The affected products include single-lumen uncoated or heparin-coated catheters, with heparin-coated catalog numbers designated by the suffix BH. The recall covers specific catalog numbers and lots distributed worldwide, including the United States, Puerto Rico, Australia, Germany, China, Chile, the Dominican Republic, Panama, Israel, Brazil, and Canada.
The recall is due to a manufacturing process issue that may lead to catheter tip fracture and/or separation. Potential adverse events include loss of device function, the need for medical intervention to retrieve a separated segment, or complications resulting from a separated tip occluding blood flow to end organs. These catheters are used in venous or arterial pressure monitoring, blood sampling, and the administration of drugs and fluids.
Healthcare facilities and consumers should stop using the affected catheter sets and trays immediately. Users should contact Cook Inc. for further instructions on how to return the products or obtain replacements.
The recalled product
- Product
- Single Lumen Central Venous Catheter Sets and Trays The subject sets and trays are comprised of a single-lumen uncoated or heparin-coated catheter. Product catalog numbers with heparin coating are designated by the suffix BH.
- Manufacturer
- Cook Inc.
- Category
- Medical Device — Catheters
- Affected units
- 1,341
Distribution
Part of a larger recall action
This product is one of 4 recalled by Cook Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 4 products in this recall →Related recalls
Same manufacturer · Cook Inc.
See all →- HighSkinny Needle with Chiba Tip recalled for debris contamination
FDA (Devices) · 2021-12-29
- HighCook Flexor Check-Flo Introducer recalled for size mislabeling
FDA (Devices) · 2021-12-22
- ModerateFlexor Check-Flo Introducer Recalled for Mislabeled Caliber Size
FDA (Devices) · 2021-12-22
- HighTransseptal Needles Recalled Due to Rust Contamination Risk
FDA (Devices) · 2021-11-24
- HighTransseptal Needle with Catheter Recalled Due to Rust Contamination Risk
FDA (Devices) · 2021-11-24
Same hazard · device fracture
See all →- SevereBoston Scientific Recalls Imager II Angiographic Catheters Due to Tip Fracture Risk
FDA (Devices) · 2026-09-30
- HighHowmedica Recalls Orthopaedic Implants Due to Potential UHMWPE Oxidation
FDA (Devices) · 2026-09-23
- SevereHowmedica Recalls Orthopaedic Implants Due to Potential UHMWPE Oxidation
FDA (Devices) · 2026-09-23
- HighHowmedica Recalls Orthopaedic Implant Components Due to Material Aging
FDA (Devices) · 2026-09-23
- HighHowmedica Recalls Orthopaedic Implants Due to Aged Polyethylene Material
FDA (Devices) · 2026-09-23
Similar recalls
- ModerateCook Inc. Recalls Central Venous Catheter Trays Due to Labeling Error
FDA (Devices) · 2018-03-21
- ModerateCook Inc. Recalls Central Venous Catheter Sets Due to Fit Issues
FDA (Devices) · 2018-02-21
- ModerateCook Inc. Recalls Central Venous Catheters Due to Fit Issues
FDA (Devices) · 2018-02-21
- ModerateCook Inc. Recalls Spectrum Central Venous Catheter Trays Due to Fit Issues
FDA (Devices) · 2018-02-21
- SevereCook Inc. Recalls Beacon Tip Catheters Due to Tip Fracture Risk
FDA (Devices) · 2016-08-31
- ModerateCook Central Venous Catheter Tray Recalled for Fit Issues
FDA (Devices) · 2018-02-21