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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 Medical see related information
Date Initiated by Firm November 21, 2014
Date Posted December 30, 2014
Recall Status1 Completed
Recall Number Z-0899-2015
Recall Event ID 69842
510(K)Number K041399  
Product Classification Needle, hypodermic, single lumen - Product Code FMI
Product 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.
Code Information Lot Number: 2755713
Recalling Firm/
Manufacturer		 Smiths Medical ASD, Inc.
10 Bowman Dr
Keene NH 03431-5043
For Additional Information Contact Shirley 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
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.
Quantity in Commerce 10,000
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
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = FMI and Original Applicant = SMITHS MEDICAL ASD, INC.
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