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U.S. Department of Health and Human Services

Class 2 Device Recall Portex Arterial Blood Sampling Line Draw Syringes

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  Class 2 Device Recall Portex Arterial Blood Sampling Line Draw Syringes see related information
Date Initiated by Firm November 22, 2013
Date Posted March 12, 2014
Recall Status1 Terminated 3 on November 20, 2020
Recall Number Z-1187-2014
Recall Event ID 66837
510(K)Number K952516  
Product Classification Tubes, vials, systems, serum separators, blood collection - Product Code JKA
Product 4043E: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ device (for sale in Europe only)

Arterial Blood Sampling Line Draw Syringes are sterile, single-use devices, in-vitro diagnostic devices used for the drawing of arterial blood via an arterial line. The product is not for injection.
Code Information 2476330 2476331 2485112 2485113 2485115 2493970 2493971 2493972 2506817 2511213 2525787 2529542 2536822 2538273 2542763 2459801 2467733 2467734
Recalling Firm/
Manufacturer		 Smiths Medical ASD, Inc.
10 Bowman Dr
Keene NH 03431-5043
For Additional Information Contact
800-258-5361
Manufacturer Reason
for Recall		 issue with the plunger tip of the Portex¿ Arterial Blood Sampling Line Draw Syringes
FDA Determined
Cause 2		 Component change control
Action Smiths Medical sent an Urgent Field Safety Notice dated November 22, 2013, to all affected consignees via FedEx beginning on November 23, 2013. Distributors were instructed to notify their customers. Customers were instructed to inspect their inventory for the affected product and quarantine the affected syringes. Complete and return the attached Urgent Field Safety Notice Confirmation Form by fax to 603-358-1017 or by email to LineDraw@smiths-medical.com. Upon receipt of the completed form, a customer service representative will contact them to arrange for exchange of their unused affecte devices for credit or replacement. Customers were instructed to forward the notice to all personnel who need to be aware within their organization and to any organization where the potentially affected devices have been transferred. Customers were instructed to report any issues with the product to Smiths Medical's Global Complaint Department at 1-866-216-8806 or globalcomplaints@smiths-medical.com. For questions regarding this recall call 603-352-3812.
Distribution Worldwide Distribution - USA including AL, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV. Internationally to Australia, Austria, Belgium, Belize, Brazil, Canada, Czech Republic, Denmark, England, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Netherlands, Norway, Poland, Scotland, Spain, and Sweden.
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 = JKA and Original Applicant = SMITHS INDUSTRIES MEDICAL SYSTEMS, INC.
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