Hypodermic Needle Pro Edge" Safety Device with Syringe 20G x1 10mL Luer lock syringe; Reorder Number: 4102010 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.
This recall has been completed (originally issued December 30, 2014).
- Company
- Smiths Medical Asd, Inc.
- Recall Initiated
- November 21, 2014
- Posted
- December 30, 2014
- Recall Number
- Z-0898-2015
- Quantity
- 47,200
- Firm Location
- Keene, NH
- Official Source
- View on FDA website ↗
Reason for Recall
Needle is not captured in the needle safety sheath in specific lots.
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
Lot / Code Info
Lot Numbers: 2756526, 2771498
Root Cause
Process control
Action Taken
Smith Medical sent on 11/24/2014, consignees an Urgent Field Safety Notice via FedEx Overnight. The notification instructs customers to inspect their inventory and complete and return the attached Urgent Field Safety Notice Confirmation Form to coordinate return of affected product to Smiths Medical for replacement/credit. For questions regarding this information, please contact Smiths Medicals Customer Service Department at 800-258-5361.