CLASS II Device recall · Reported 9 Sep 2015 · FDA Enforcement Report
Mahurkar Acute Dual Lumen Catheter Tray recalled by Covidien
Covidien is recalling Mahurkar Acute Dual Lumen Catheter Tray, High Flow¿ Pre-Curved with IC* Safety, distributed nationwide in the US. The recall was initiated on 6 Aug 2015 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2527-2015
- FDA event ID
- 71893
- Recalling firm
- Covidien, North Haven, CT
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 6 Aug 2015
- FDA classified
- 1 Sep 2015
- Reported
- 9 Sep 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Heart & Vascular Devices
Timeline
| 6 Aug 2015 | Recall initiated by company | |
| 1 Sep 2015 | Classified by FDA | +26 days |
| 9 Sep 2015 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Sterility may be compromised
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Mahurkar Acute Dual Lumen Catheter Tray, High Flow¿ Pre-Curved with IC* Safety Components, 13.5 FR x 13.5 cm Item Code: 8888135139 Product Usage: Sterile Delivery are indicated for use in flushing compatible intravenous administration sets and indwelling intravascular access devices.
Where it was distributed
US Nationwide Distribution
Questions about this recall
Why was it recalled?
Sterility may be compromised
Which lots are affected?
Lot Numbers: 1506500122
Where was it sold?
US Nationwide Distribution
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
12 other products · FDA event 71893This product is part of a recall event; the main page for the event is Monoject 0.9% Saline Flush Prefill Double recalled by Covidien.
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