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U.S. Department of Health and Human Services

Class 2 Device Recall 18 gage XTW needles

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  Class 2 Device Recall 18 gage XTW needles see related information
Date Initiated by Firm September 12, 2008
Date Posted November 03, 2008
Recall Status1 Terminated 3 on May 06, 2009
Recall Number Z-0131-2009
Recall Event ID 49531
510(K)Number K934901  K003731  
Product Classification Introducer needle - Product Code DYB
Product 18 gage XTW needles, sold as a component in SafeSheath Hemostatic Tear-away Introducer System with Infusion Side Port kits or sold Bulk Non Sterile (BNS).
Code Information Lot numbers S25589, S25590, S25756, S25769, S25787, S25909, S25910X1, S25911, S25924, S25948, S25949, S25950, S25951, S25972, S25973, S25974, S25975, S25996, S25997, S25998, S26001, S26002, S26003, S26009, S26010, S26011, S26012, S26039,S26040, S26044, S26045, S26058, S26059, S26060, S26063, S26064,S26088, S26089, S26092, S26095, S26102, S26146, S26177, S26178, S26182, S26183, S26198, S26203, S26214, S26217, S26218, S26230, and S26345.
Recalling Firm/
Manufacturer		 Thomas Medical Products Inc
65 Great Valley Pkwy
Malvern PA 19355-1302
For Additional Information Contact Tim Stoudt
610-296-3000
Manufacturer Reason
for Recall		 Difficulty inserting guidewire through introducer needle. Needle hub is not tapered down to the needle cannula.
FDA Determined
Cause 2		 Process control
Action On 9/11/08, Thomas Medical Products issued letters to the distributors informing them of the problem, to cease distribution and await further instructions. Additional instructions to the distributors were to notify all their account via an advisory notice and request that the user not use the needle supplied with the kit and to replace with another commercially available sterile 18 gage introducer needle.
Quantity in Commerce 246,585 needles
Distribution Nationwide distribution via distributors in CA, MA, and MN.
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.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = DYB and Original Applicant = THOMAS MEDICAL PRODUCTS, INC.
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