—#124264

Product

4042-2: 3 mL Line Draw, Luer lock syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro device 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.

FDA product code: JKA — Tubes, Vials, Systems, Serum Separators, Blood Collection
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: K952516
Affected lot / code info: 2463876 2472511 2476324 2476325 2480609 2485108 2489875 2493965 2503422 2503423 2506814 2511211 2513709 2521588 2529536 2533320 2536817 2547283 2551262 2551263 2560919 2560920 2569052 2569053 2574217 2463876

Why it was recalled

issue with the plunger tip of the Portex Arterial Blood Sampling Line Draw Syringes

Root cause (FDA determination)

Component change control

Action the firm took

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.

Recalling firm

Firm: Smiths Medical ASD, Inc.
Address: 10 Bowman Dr, Keene, New Hampshire 03431-5043

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2013-11-22
Posted by FDA: 2014-03-12
Terminated: 2020-11-20
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #124264. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.