FDA Enforcement
Class II
Completed
Hypodermic Needle Pro¿ Edge" Safety Device 20G x1; Reorder Number: 402010 Product Usage: The Needle Pro¿ Edge Safety Hypodermic Needle is intended for injection or aspiration of fluids utilizing a luer lock or luer slip syringe.
Recall: Z-0897-2015
·
Reported January 7, 2015
Enforcement
- Recall Number
- Z-0897-2015
- Event ID
- 69842
- Classification
- Class II
- Status
- Completed
- Product Type
- Devices
- Firm
- Smiths Medical ASD, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- January 7, 2015
- Initiation Date
- November 21, 2014
- Classification Date
- December 30, 2014
- Address
- 10 Bowman Dr, N/A, Keene, NH, 03431-5043, United States
Description
Hypodermic Needle Pro¿ Edge" Safety Device 20G x1; Reorder Number: 402010 Product Usage: The Needle Pro¿ Edge Safety Hypodermic Needle is intended for injection or aspiration of fluids utilizing a luer lock or luer slip syringe.
Reason
Needle is not captured in the needle safety sheath in specific lots.
Code Info
Lot Numbers: 2731779, 2763138, 2771516, 2771517
Distribution
US Nationwide Distribution in the states of AZ CA FL GA IL IN LA MA MN MO MS MT NC ND NJ NV NY OH OR PA RI TN TX VA WA WI WV
Quantity
334,000