Mahurkar Elite Acute Dual Lumen Catheter Tray Recalled for Sterility Concerns
Covidien LLC is recalling 53 kits of Mahurkar Elite 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 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 involves a medical device where sterility may be compromised, posing a risk of harm (infection) without reported injuries, which aligns with the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Covidien LLC is recalling 53 kits of the Mahurkar Elite Acute Dual Lumen Catheter Tray, Straight Extensions with IC* Safety Components, 12 Fr x 20 cm (Item Code: 8888221420). The affected product is identified by Lot Number 1506200118.
The recall was initiated because the sterility of the devices may be compromised. These sterile delivery systems are indicated for use in flushing compatible intravenous administration sets and indwelling intravascular access devices.
The affected units were distributed nationwide in the United States. Consumers and healthcare facilities should stop using the affected product and contact the manufacturer for further instructions.
The recalled product
- Product
- Mahurkar" Elite Acute Dual Lumen Catheter Tray, Straight Extensions with IC* Safety Components, 12 Fr x 20 cm Item Code:8888221420 Product Usage: Sterile Delivery are indicated for use in flushing compatible intravenous administration sets and indwelling intravascular…
- Manufacturer
- Covidien LLC
- Category
- Medical Device — Catheter
- Affected units
- 53
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: 1506200118
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.
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