Recall Z-2190-2014
Codman & Shurtleff, Inc. · initiated July 3, 2014
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Codman Certas - In Line Valve with SIPHONGUARD, Unitized Catheter and Accessories; Product Code: 82-8806 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.
Codes / lots: Lot Numbers: CMBC2Z, CMBCPR, CMCC2T, CMDB7C, CMDBHC, CMJC49, CMJCMD, CMLBLZ, CMMB14, CNDBCY, CNDCV2, CNJCFT, CNKBHS, CNLB57, CNMDNL, CNNCWD, CNPB1Z, CPBB3J, CPBDBB, CPCCMO, CPDBYK
Reason for recall
To clarify the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the product's Instructions for Use (IFU).
FDA-determined cause: Device Design
Action taken
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) 685-7325. For questions regarding this recall call 508-828-2726.
Details
- Recall number
- Z-2190-2014
- Initiated
- July 3, 2014
- Posted by FDA
- August 12, 2014
- Terminated
- January 30, 2017
- Product code
- JXG – Shunt, Central Nervous System And Components
- 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, Denmark, Egypt, Finland, France, Germany, Great Britain, Greece, Hungary, Ireland, Israel, Italy…
- Recalling firm
- Codman & Shurtleff, Inc., Raynham, MA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2184-2014 Class II | Codman Certas - In Line Valve Only; Product Code: 82-8800 The Codman Certas Programmable…To clarify the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the product's… | 07/03/2014Terminated |
| Z-2185-2014 Class II | Codman Certas - In Line Valve with Catheter and Accessories; Product Code: 82-8801 The…To clarify the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the product's… | 07/03/2014Terminated |
| Z-2186-2014 Class II | Codman Certas - In Line Valve with Unitized Catheter and Accessories; Product Code:…To clarify the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the product's… | 07/03/2014Terminated |
| Z-2187-2014 Class II | Codman Certas - In line Valve with Unitized BACTISEAL Catheter and Accessories; Product…To clarify the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the product's… | 07/03/2014Terminated |
| Z-2188-2014 Class II | Codman Certas - In Line Valve only with SIPHONGUARD Device; Product Code: 82-8804 The…To clarify the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the product's… | 07/03/2014Terminated |
| Z-2189-2014 Class II | Codman Certas - In Line Valve with SIPHONGUARD Device, Catheter and Accessories; Product…To clarify the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the product's… | 07/03/2014Terminated |
| Z-2191-2014 Class II | Codman Certas - In Line Valve with SIPHONGUARD Device, Unitized BACTISEAL Catheter and…To clarify the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the product's… | 07/03/2014Terminated |