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U.S. Department of Health and Human Services

Class 2 Device Recall Smiths Medical

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 Class 2 Device Recall Smiths Medicalsee related information
Date Initiated by FirmNovember 21, 2014
Date PostedDecember 30, 2014
Recall Status1 Completed
Recall NumberZ-0898-2015
Recall Event ID 69842
510(K)NumberK041399 
Product Classification Needle, hypodermic, single lumen - Product Code FMI
ProductHypodermic 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.
Code Information Lot Numbers: 2756526, 2771498
Recalling Firm/
Manufacturer		 Smiths Medical ASD, Inc.
10 Bowman Dr
Keene NH 03431-5043
For Additional Information ContactShirley Duggan
781-763-9335
Manufacturer Reason
for Recall		Needle is not captured in the needle safety sheath in specific lots.
FDA Determined
Cause 2		Process control
ActionSmith 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.
Quantity in Commerce47,200
DistributionUS 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
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database510(K)s with Product Code = FMI
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