Recall Z-2188-2014 ยท JXG Shunt, Central Nervous System And Components
Codman & Shurtleff, Inc.
Codman Certas - In Line Valve only with SIPHONGUARD Device; Product Code: 82-8804 The Codman Certas Programmable valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the management of hydrocephalus.
| Date | Aug 12, 2014 (initiated Jul 3, 2014) |
| Status | Terminated |
| Reason | To clarify the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the product's Instructions for Use (IFU). |
| Root cause | Device Design |
| Action | Codman Neuro sent an Urgent Medical Device Safety Notification dated July 17, 2014, to clinicians who use the device. The notification clarifies the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the product's Instructions for Use (IFU). Consignees are also asked to complete the enclosed Acknowledgement Form and fax the completed form to 1-888-239-1305. For questions or concerns regarding this notification, consignees are instructed to contact their local Codman Neuro Representative or Scientific and Medical Affairs at SciMedAffairs@its.jnj.com or (866) 685-732 |
| Quantity | 9,498 devices total |
| Distribution | Worldwide Distribution - USA including AL, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, WY; and Internationally to: Canada, Australia, Austria, Belgium, Brazil, Czech Republic, De |
| FDA record | Open on fda.gov |