Mahurkar Elite Acute Dual Lumen Catheter Tray Recalled for Sterility Concerns
The FDA is recalling 67 kits of Mahurkar Elite Acute Dual Lumen Catheter Trays because sterility may be compromised. The product was distributed nationwide.
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 3/5 (High).
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 is classified as FDA Class II, and the hazard involves a risk of harm (compromised sterility) where injury has not yet been reported, which aligns with the High severity criteria.
Plain-English summary
The U.S. Food and Drug Administration (FDA) is recalling 67 kits of the Mahurkar Elite Acute Dual Lumen Catheter Tray, Curved Extensions with IC* Safety Components, 12 Fr x 16 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 was initiated because the sterility of the product may be compromised. The affected lots are 1506200119 and 1511100102. The product was distributed nationwide in the United States.
Healthcare facilities and consumers should stop using the recalled product immediately. Users should contact their supplier or the manufacturer for instructions on how to return the product or obtain a replacement.
The recalled product
- Product
- Mahurkar Elite Acute Dual Lumen Catheter Tray, Curved Extensions with IC* Safety Components, 12 Fr x 16 cm Item Code: 8888222416 Product Usage: Sterile Delivery are indicated for use in flushing compatible intravenous administration sets and indwelling intravascular access…
- Manufacturer
- Covidien LLC
- Category
- Medical Device — Catheters
- Affected units
- 67
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: 1506200119 1511100102
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
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