FDA Enforcement
Class II
Terminated
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 access devices.
Recall: Z-2530-2015
·
Reported September 9, 2015
Enforcement
- Recall Number
- Z-2530-2015
- Event ID
- 71893
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Covidien LLC
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- September 9, 2015
- Initiation Date
- August 6, 2015
- Classification Date
- September 1, 2015
- Termination Date
- June 29, 2017
- Address
- 60 Middletown Ave, N/A, North Haven, CT, 06473-3908, United States
Description
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 access devices.
Reason
Sterility may be compromised
Code Info
Lot Numbers: 1506200118
Distribution
US Nationwide Distribution
Quantity
53 kits