| Class 2 Device Recall Portex Arterial Blood Sampling Line Draw Syringes | |
Date Initiated by Firm | November 22, 2013 |
Date Posted | March 12, 2014 |
Recall Status1 |
Terminated 3 on November 20, 2020 |
Recall Number | Z-1183-2014 |
Recall Event ID |
66837 |
510(K)Number | K952516 |
Product Classification |
Tubes, vials, systems, serum separators, blood collection - Product Code JKA
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Product | 4043G-2: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro device and ice bag
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 |
2489881 2503429 2513713 2525788 2555872 2472514 |
Recalling Firm/ Manufacturer |
Smiths Medical ASD, Inc. 10 Bowman Dr Keene NH 03431-5043
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = JKA
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