G1469J: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro device (for sale in Japan 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.
This recall has been terminated (originally issued March 12, 2014).
- Company
- Smiths Medical Asd, Inc.
- Recall Initiated
- November 22, 2013
- Posted
- March 12, 2014
- Terminated
- November 20, 2020
- Recall Number
- Z-1188-2014
- Firm Location
- Keene, NH
- Official Source
- View on FDA website ↗
Reason for Recall
issue with the plunger tip of the Portex Arterial Blood Sampling Line Draw Syringes
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.
Lot / Code Info
2467804 2480661 2503528 2503529 2521653 2529597 2529598 2551329 2572218 2572220 2467805
Root Cause
Component change control
Action Taken
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.