Mahurkar Acute Dual Lumen Catheter Tray Recalled for Sterility Concerns
Covidien LLC is recalling 96 kits of Mahurkar Acute Dual Lumen Catheter Trays because sterility may be compromised.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 is classified as FDA Class II, and the hazard involves compromised sterility in a medical device, which poses a significant risk of infection or serious injury.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class II recall for 96 kits of Mahurkar Acute Dual Lumen Catheter Trays, High Flow Straight Extensions with IC* Safety Components, 13.5 FR x 13.5 cm. The product is manufactured by Covidien LLC and is indicated for use in flushing compatible intravenous administration sets and indwelling intravascular access devices.
The recall is being conducted because the sterility of the product may be compromised. The affected lot number is 1508200108. The product was distributed nationwide in the United States.
Healthcare providers and facilities should stop using the affected product immediately. Consumers should not use the product and should contact their healthcare provider or the manufacturer for further instructions.
The recalled product
- Product
- Mahurkar Acute Dual Lumen Catheter Tray, High Flow Straight Extensions with IC* Safety Components, 13.5 FR x 13.5 cm Item Code: 8888135137 Product Usage: Sterile Delivery are indicated for use in flushing compatible intravenous administration sets and indwelling…
- Manufacturer
- Covidien LLC
- Category
- Medical Device — Catheter
- Affected units
- 96
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)
- Lot Numbers: 1508200108
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 13 recalled by Covidien LLC 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 13 products in this recall →Related recalls
Same manufacturer · Covidien LLC
See all →- ModerateEndoFLIP System Recall Due to Incorrect Catheter Expiration Flags
FDA (Devices) · 2026-08-26
- ModerateCovidien Shiley Disposable Decannulation Plug product labeling error
FDA (Devices) · 2026-07-08
- ModerateCovidien 9 Fr Mon-a-Therm temperature probes lack FDA clearance
FDA (Devices) · 2026-06-10
- ModerateCovidien esophageal stethoscope temperature sensors lack FDA clearance
FDA (Devices) · 2026-06-10
- ModerateShiley tracheostomy tubes recalled over incorrect display box labeling
FDA (Devices) · 2026-06-10
Same hazard · sterility compromise
See all →- ModerateAVID Medical Recalls Halyard IV Start Kits Due to Packaging Seal Issues
FDA (Devices) · 2026-09-30
- HighMedline Recalls Cataract Convenience Kits Due to Open Sterile Seals
FDA (Devices) · 2026-09-23
- HighMedline Myringotomy Kits Recalled for Potential Sterility Compromise
FDA (Devices) · 2026-09-23
- HighMedline Anesthesia Pain Kits Recalled for Potential Sterility Compromise
FDA (Devices) · 2026-09-23
- HighMaquet Percutaneous Insertion Kit Recalled for Sterile Barrier Integrity Issues
FDA (Devices) · 2026-09-23
Similar recalls
- SevereMahurkar Dialysis Catheters Recalled Due to Leaking Hub Defect
FDA (Devices) · 2023-01-18
- HighDialysis catheter trays recalled over seal integrity of header bag packaging
FDA (Devices) · 2025-11-12
- HighStraight extension catheter trays recalled over header bag seal integrity
FDA (Devices) · 2025-11-12
- HighStraight extension catheter trays 24 cm recalled over header bag seals
FDA (Devices) · 2025-11-12
- HighMedtronic Recalls Unsterilized Acute Dual Lumen Dialysis Catheters
FDA (Devices) · 2018-03-21
- SevereMahurkar Dialysis Catheter Center Lumen Occlusion, FDA Class I Recall
FDA (Devices) · 2023-08-23