Codman Certas - In Line Valve with Catheter and recall
Codman Certas - In Line Valve with Catheter and Accessories; Product Code: 82-8801 The Codman Certas Programmable valve is an implantable device that…
Why was Codman Certas - In Line Valve with Catheter and recalled?
To clarify the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the product's Instructions for Use (IFU).
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot Numbers: CMBBP2, CMCBLG, CMDBHG, CMFBB8, CMHDFW, CMJCPY, CMLBLW, CMLCKP, CMMBCY, CMMC3F, CMNBFC, CMNCDW, CMPB96, CNCCLK, CNJBWO, CNJC4B, CNJC4W, CNKBWN, CNKCL1, CNLBR3, CNLBZF, CNMDM1, CNNCPL, CNNDH4, CNPBRM, CPBBGP, CPBC97, CPBCRW, CPBCVD, CPCBHB, CPCCMP, CPDBYD, CPDBYF
- Product
- Codman Certas - In Line Valve with Catheter and Accessories; Product Code: 82-8801 The Codman Certas Programmable valve is an implantable device that…
- Recalling firm
- Codman & Shurtleff, Inc.
- 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, Kuwait, Lebanon, Luxembourg, Netherlands, Norway, Portugal, Russia, Saudi Arabia, Slovak Republic, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey.
- Recall date
- August 20, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)