Perfusion Pack, Rx only, Sterile EO
Recall
- Recall Number
- Z-0770-2019
- Event Number
- 81667
- Firm
- LivaNova USA
- FEI Number
- 1718850
- Product Code
- DWF
- Status
- Terminated
- Root Cause
- Process control
- Initiated
- November 9, 2018
- Terminated
- May 3, 2022
- Address
- 14401 W 65th Way, Arvada, CO, 80004-3503
Description
Perfusion Pack, Rx only, Sterile EO
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.
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 stopcocks in the pack with the spare provided by the firm. The original stopcocks should be destroyed/ discarded. 4) Contact your firm Representative if additional replacement stopcocks are required. In addition, customers were asked to complete and return the attached Customer Response Form. Also, to assure within their organization that the correction notice is communicated to all personnel who need to be aware of it. For questions about this Medical Device Correction, please contact (800) 986-4702 or e-mail [email protected]
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
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