Cook Inc. Recalls Left Atrial Catheter Sets Due to Labeling Error
Cook Inc. is recalling 56 Left Atrial Catheter Sets because the labels failed to state that the product is heparin-coated.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard is a minor labeling error regarding heparin coating, which fits the criteria for moderate severity involving labeling issues.
Plain-English summary
Cook Inc. is recalling 56 units of the Left Atrial Catheter Set, Catalog # C-ULAP-5.0-60-DTK-BH, all lots. The recall was initiated because the product labels do not state that the product is heparin-coated.
The affected products were distributed nationally. The source text does not specify the number of reported illnesses or injuries associated with this recall.
Healthcare providers and consumers should stop using the affected Left Atrial Catheter Sets and contact Cook Inc. for further instructions or a replacement.
The recalled product
- Product
- Left Atrial Catheter Set
- Manufacturer
- Cook Inc.
- Category
- Medical Device — Catheter
- Hazard
- Affected units
- 56
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Catalog # C-ULAP-5.0-60-DTK-BH ALL LOTS
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 20 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 20 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 · mis labeling
See all →- ModerateMedline Trach Tube Kit Recalled for Component Labeling Discrepancy
FDA (Devices) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- ModerateOlympus Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling
FDA (Devices) · 2026-09-02
- HighSura Tanmen Ramen Noodles Recalled for Undeclared Fish Allergens
FDA (Food) · 2026-09-02
- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-09-02