Codman Certas - In Line Valve with SIPHONGUARD¿ Device recall
Codman Certas - In Line Valve with SIPHONGUARD¿ Device, Unitized BACTISEAL¿ Catheter and Accessories; Product Code: 82-8807 The Codman Certas…
Why was Codman Certas - In Line Valve with SIPHONGUARD¿ Device 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: CLPCNB, CMBCPT, CMCC2W, CMDB6L, CMDDJV, CMI<B24, CMLCKN, CMMC3H, CMMCGV, CMNBZH, CNBB11, CNCB6N, CNCCLH, CNCCU, CNCCZ2, CNCCZ3, CNDB69, CNDB8C, CNDBRJ, CNDCVO, CNGBK4, CNHCZR, CNJB1G, CNJC4T, CNJCMR, CNKBZD, CNLBVM, CNLBZC, CNMBFL, CNMBFM, CNMDNK, CNNDH1, CNPBRL, CNPCLV, CPBBGT, CPBCR3, CPBCR4, CPCBHC, CPCBHD, CPCCMN, CPDBYL, CPDCC3
- Product
- Codman Certas - In Line Valve with SIPHONGUARD¿ Device, Unitized BACTISEAL¿ Catheter and Accessories; Product Code: 82-8807 The Codman Certas…
- 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)