Class 2 Device Recall Terumo TenderFlow Pediatric Venous Cannulae

• Date Initiated by Firm: May 23, 2014
• Date Posted: July 23, 2014
• Recall Status: Terminated on February 24, 2015
• Recall Number: Z-2103-2014
• Recall Event ID: 68404
• 510(K)Number: K062597 K090878
• Product Classification: Catheter, cannula and tubing, vascular, cardiopulmonary bypass - Product Code DWF
• Product: Terumo TenderFlow Pediatric Venous Cannulae, 8, 10, 12, 14, 16, 18, 20, 22 & 24 Fr angled & straight tip, 1/4" & 3/8" flare,; ; Product Usage:; Venous Return Cannula is indicated for venous drainage during cardiopulmonary bypass surgery for dual cannulation of the superior and inferior vena cava
• Code Information: Part No. 813542, Lot #: AM000378; Part No. 813541, Lot #: AM002689; Part No. 813544, Lot #: AM006016, AM017817; Part No. 813546, Lot #: AM002709, AM006018, AM006048, AM017262; Part No. 813545, Lot #: AM002705, AM006046, AM007636; Part No. 813548, Lot #: AM002707, AM006050, AM017681; Part No. 813547, Lot #: AM002697, AM006020, AM007724; Part No. 813550, Lot #: AM001312, AM004268, AM007732, AM018316; Part No. 813549, Lot #: AM002717, AM006052, AM007637; Part No. 813552, Lot #: AM003778, AM007725; Part No. 813554, Lot #: AM001309; Part No. 813551, Lot #: AM002702, AM007635; Part No. 813553, Lot #: AM002708; Part No. 813556, Lot #: AM007733; Part No. 813555, Lot #: AM002719; Part No. 813557, Lot #: AM007726; Part No. 813560, Lot #: AM018160; Part No. 813559, Lot #: AM008235; Part No. 813561, Lot #: AM007639; Part No. 813566, Lot #: AM004227, AM017924 & Part No. 813565, Lot #: AM001315, AM006072.
• Recalling Firm/ Manufacturer: Terumo Cardiovascular Systems Corporation; 6200 Jackson Rd; Ann Arbor MI 48103-9586
• For Additional Information Contact: 800-521-2818
• Manufacturer Reason for Recall: During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product specifications
• FDA Determined Cause: Process control
• Action: Terumo sent an Urgent Medical Device Recall letters dated June 27, 2014 to their customers. The letter identified the affected product, problem and actions to be taken. The letter instructed customers to 1. Review this Medical Device Recall notice, 2. Assure that all users in your institution have received notice of this issue and remove any affected units from use, 3. Fill out the Product Tracking Sheet (enclosed), indicating the number of affected units at your institution and fax to 1-877-907-7509 or email to terumo4967@stericycle.com. 4. Complete the Packing Slip (enclosed) and follow the packing instructions to return the affected product, and 5. Terumo CVS will issue credit once the affected units are returned. For questions call Terumo CVS c/o Stericycle 1-866-629-6181.
• Quantity in Commerce: 14,380 units
• Distribution: Worldwide Distribution - US (nationwide) in the states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV & WY and the countries of : Australia, Belgium, Canada, Chile, Japan, Malaysia, Mexico, Singapore, Taiwan, Thailand, United Arab Emirates (UAE) & United Kingdom.
• 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 = DWF and Original Applicant = TERUMO CARDIOVASCULAR SYSTEMS CORP.