Cook Inc. Recalls Spectrum Central Venous Catheter Trays Due to Fit Issues
Cook Inc. is recalling 304 Spectrum Central Venous Catheter Trays because the catheters may not fit over the guide wire, potentially causing procedure delays.
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. The hazard involves a procedural delay rather than a direct risk of serious injury or death, fitting the criteria for a moderate severity rating.
Plain-English summary
Cook Inc. is recalling 304 units of the Spectrum Central Venous Catheter Tray Minocycline/Rifampin Antibiotic Impregnated. The affected catalog identifiers are C-UTLMY-501J-ABRM-HC-FST and C-UTLMY-501J-ABRM-HC-IHI-FST. The recall involves specific lots with expiration dates of May 1, 2019, and September 1, 2019.
The recall was initiated because the central venous catheters may not fit over the guide wire. This defect potentially causes procedure delays. The product is used for the intravenous administration of nutrient fluids, chemotherapeutic agents, and other drugs for therapy, blood sampling, blood delivery, and venous pressure monitoring.
The affected units were distributed worldwide, including nationwide in the United States and in Belgium, India, Italy, Spain, and the United Kingdom. Healthcare facilities and consumers should stop using the affected lots and contact Cook Inc. for further instructions.
The recalled product
- Product
- Spectrum Central Venous Catheter Tray Minocycline/Rifampin Antibiotic Impregnated, Catalog Identifiers: C-UTLMY-501J-ABRM-HC-FST and C-UTLMY-501J-ABRM-HC-IHI-FST Usage: The Spectrum Central Venous Catheter is used for the intravenous administration of nutrient fluids, chemoth
- Manufacturer
- Cook Inc.
- Category
- Medical Device — Catheters
- Hazard
- Affected units
- 304
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 (7)
- Lot Number (Expiration date): 7693203 (01-May-2019)
- 7611811 (01-May-2019)
- 7625110 (01-May-2019)
- 7625111 (01-May-2019)
- 7689802 (01-May-2019)
- 7713113 (01-May-2019)
- and 7724842 (01-September-2019)
Distribution
Part of a larger recall action
This product is one of 5 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 5 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 · procedure delay
See all →- Moderateda Vinci SP Instrument Arm Drape may detach during surgical procedures
FDA (Devices) · 2026-07-22
- ModerateTourniquet systems recalled over screens that may freeze in non-English settings
FDA (Devices) · 2026-02-04
- ModerateA.T.S. 3200TS tourniquets recalled over screens that may freeze
FDA (Devices) · 2026-02-04
- ModerateNeurostimulator clinician programmer app recalled over faults during device use
FDA (Devices) · 2026-01-21
- HighSurgical robot console motors recalled over an error that locks ergonomics
FDA (Devices) · 2025-12-31