FDA Recall Completed

Hypodermic Needle Pro Edge" Safety Device with Syringe 20G x1 5mL Luer lock syringe; Reorder Number: 452010 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-0899-2015 · Initiated November 21, 2014

Recall

Recall Number
Z-0899-2015
Event Number
69842
Firm
Smiths Medical ASD, Inc.
FEI Number
1217052
Product Code
FMI
Status
Completed
Root Cause
Process control
Initiated
November 21, 2014
Posted
December 30, 2014
Address
10 Bowman Dr, Keene, NH, 03431-5043

Description

Hypodermic Needle Pro Edge" Safety Device with Syringe 20G x1 5mL Luer lock syringe; Reorder Number: 452010 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.

Action

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.

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

10,000