Recall Z-0770-2019 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
LivaNova USA
Perfusion Pack, Rx only, Sterile EO
| Date | Nov 9, 2018 |
| Status | Terminated |
| Reason | 4-way stopcocks and stopcock manifold assembled in certain perfusion tubing systems, indicated for use in surgical procedures requiring extracorporeal support for periods of up to six hours, may leak or be occluded. |
| Root cause | Process control |
| Action | On 11/09/2018 Medical Device Correction Notices were mailed to customers via UPS First Overnight. Customers were advised: 1) Inspect your stock and identify Perfusion Tubing System(s) belonging to the impacted lots in inventory, as noted in Attachment 1. 2) The recalling firm will be shipping one case of sterile stopcocks (part number: SCO4S) and manifolds (part number: 020581600) to your facility as an immediate replacement for those remaining that may be defective in your impacted Perfusion Tubing System stock. 3) As each affected pack is opened for use, please replace the original stopcoc |
| Quantity | 483 |
| Distribution | Worldwide Distribution - Domestic (US) Consignees: AR, AZ, CA, CO, CT, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, VA, WA, WI, WV, MS; Foreign (OUS) Consignees: Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K881330 | COBE HEART/LUNG PERFUSION AND CARDIOPLEGIA PACK Cobe Laboratories, Inc., Jun 10, 1988 |