Recall Z-0207-2016 ยท LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Arrow International Inc
ARROW PICC Kit featuring Chlorag+ard Technology Midline Catheterization Kit ARROW Advantage5 Pressure Injectable PICC Kit Arrow Pressure Injectable Arrow PICC powered by Arrow VPS Stylet ARROW Pressure Injectable JACC with Chlorag+ard Technology For short-term or long-term peripheral access to the central venous system for intravenous therapy, blood sampling, infusion, pressure injection of contra
| Date | Nov 4, 2015 (initiated Oct 16, 2015) |
| Status | Terminated |
| Reason | Possibility that the catheter peel-away component hub tabs may prematurely detach when the practitioner begins to peel apart the sheath body from the catheter. Although the issue does not pose a significant risk to the patient, it may cause a delay of treatment when placing the catheter. |
| Root cause | Unknown/Undetermined by firm |
| Action | Arrow International sent an Urgent Medical Device Recall Notification letter dated October 16, 2015, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignees. Consignees were instructed to immediately discontinue use and quarantine any effected products. Consignees were instructed to return product, complete the enclosed Recall Acknowledgement Form and fax it to 1-855-419-8507 Attn: Customer Service or email it to recalls@teleflex.com. A customer service representative will contact consignees with a Return Goods Authorizatio |
| Quantity | 12,157 |
| Distribution | World Wide Distribution - US including AR, AL, TX, MA, CA, IA, MO, NY, AL, VA, RI, IN, TN, FL, KY, NH, SC, MD, WA, OK, IL, ME, OR, OH, PA, MI, KS, LA, TN, WV, NE, NJ, NV, GA, SD, CT, MS, CO, and Internationally to Canada and Belgium. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K112896 | ARRW EVOLUTION Arrow International (Subsidiary of Teleflex Inc.), May 10, 2012 |
| K113277 | ARROWADVANTAGES PRESSURE INJECTABLE PERIPHERALLY INSCRTED CENTRAL CATHETER KITS Arrow International, Inc., Jun 21, 2012 |
| K121941 | ARROW PICC POWERED BY ARROW VPS STYLET Arrow International (Subsidiary of Teleflex Inc.), Sep 7, 2012 |
| K122854 | ARROW GLIDETHRU PEEL-AWAY SHEATH/DILATOR INTRODUCER Arrow International (Subsidiary of Teleflex Inc.), Jan 4, 2013 |
| K132133 | CG+ ARROW JACC POWERED BY ARROW VPS STYLET Arrow International (Subsidiary of Teleflex Inc.), Sep 26, 2013 |