Reported Aug 20, 2014 · Terminated
Codman Certas - In Line Valve only with SIPHONGUARD¿ Device; Product Code: 82-8804 The Codman Certas Programmable valve…
Codman & Shurtleff, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Codman & Shurtleff, Inc. · 325 Paramount Drive · Raynham, MA · 02767
Is this the product you have?
- Codman Certas - In Line Valve only with SIPHONGUARD¿ Device
- Product Code82-8804 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
- Lot codes and dates
- Lot NumbersCMBC2W, CMDBHB, CMDDJP, CMDDJR, CMKB22, CMLCKR, CMMB1L, CMMCR5, CMNBFD, CMNCVP, CMNCYM, CMPB95, CMPBMD, CNBB13, CNBBCZ, CNCB4R, CNCB61, CNCB6L, CNDB8B, CNDBVZ, CNDCM8, CNDCM9, CNFCVH, CNFCVJ, CNHB96, CNHC8J, CNHC8L, CNHCKG, CNHCZH, CNHCZM, CNHCZT, CNJB98, CNJBWW, CNJBWY, CNJC39, CNJC4H, CNJC4J, CNJCBO, CNJCFP, CNJCG9, CNKB42, CNKBOR, CNKBTR, CNKCLO, CNKCLZ, CNLBR2, CNLBZD, CNLCW4, CNMBFK, CNMCDP, CNMCDR, CNMCDV, CNMCDW, CNMDM2, CNMDM3, CNMDNG, CNMDNH, CNNCWC, CNNCWH, CNNDH2, CNNDH3, CNPB1V, CNPB1W, CNPBRJ, CNPCLP, CPBB39, CPBB3H, CPBBGN, CPBC98, CPBCKR, CPBCKT, CPBCRO, CPCBG6, CPCBG7, CPCCBD, CPCCBF, CPCCBG, CPCCMW, CPDBYG, CPDBYH, CPDC09, CPDCC4, CPDCC6
- Amount recalled
- 9,498 devices total
This recall covers 8 products
The agency filed one notice per product. You are reading one of them; the other 7 are below.
Where it was sold
Why it was recalled
To clarify the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the product's Instructions for Use (IFU).
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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