Device Recall Codman

Lot numbers: 14B114CT, 14E011CT, and 14E366CT

General Hospital and Personal Use Devices

3

Yes

Worldwide Distribution-US (nationwide) and the countries of Canada, France, Germany, and Switzerland.

CODMAN 3000 Series Refill Set- Huber needles. || Used in combination with the CODMAN 3000 Series Constant Flow Implantable Pump || CATALOG NO. : AP-07014 || Each CODMAN 3000 Refill Kit contains 2 (two) 22 Gauge x 1.5 Huber Point Needles which are used in conjunction with a 50 mL Calibrated Syringe Barrel, Tubing Set and Stopcock for pump refills. || .

Lot Numbers: CMJB1B CMJB1C CMJB1D CMJB67 CMJB68 CMJB69 CMJB7B CMJCR6 CMJCR7 CMJCR8 CMJC1F CMJC1G CMJC1H CMJC1J CMJC1K CMJC1L CMJC1M CMKBKF CMKBKG CMKBKH CMKBK3 CMKBK4 CMKBK5 CMKBK6 CMKBK7 CMKBZ3 CMKBZ4 CMKBZ5 CMKBZ6 CMKBZ7 CMKB2Y CMKB2Z CMKB20 CMKB8L CMKCKG CMKCKH CMLBH6 CMLBMY CMLBMZ CMLBM0 CMLBM1 CMLB5P CMLB5R CMLCJR CMLCJT CMLCJV CMLC5G CMLC5H CMLC5J CMMBFR CMMBFT CMMBL5 CMMBL6 CMMCF3 CMMCF4 CMMCF5 CMMCF6 CMMC4H CMMC4J CMMC4K CMMC4L CMMC4M CMNBD9 CMNBZ4 CMNBZ5 CMNBZ6 CMNBZ7 CMNBZ8 CMNCHY CMNCHZ CMNCLW CMNCLY CMNCLZ CMNCL0 CMNCL1 CMNCL2 CMNCW5 CMNCW6 CMNCW7 CMLBJH CMMBD9 CMMCFC CMNCC1 CMNCC2

Neurological Devices

2

No

Worldwide Distribution - USA, and the countries of Canada, Austria, Brazil, Belgium, Columbia, China, Denmark, Estonia, Spain, Finland, France, Great Britain, Germany, India, Italy, Japan, Lithuania, Netherlands, New Zealand, Oman, Mexico, Portugal, Russia, Singapore, SIovenia, and Switzerland.

Codman ICP Skull Bolt Kit, Product Code: 82-6638. Single Use, disposable drill kit for gaining access to the cranium to allow for insertion and retention of intracranial cranial pressure sensor, included in the kit.

All unexpired lots

Cardiovascular Devices

2

No

Worldwide Distribution - USA (nationwide) and Internationally to Austria, Belgium, Canada, Chile, Costa, Rica, Czech Republic, Denmark, France, Germany, Great Britian/UK, Ireland, Italy, Lithuania, Malaysia, Netherlands, New Zealand, Norway, Poland, Portugal, Singapore, Slovakia, Spain, and Switzerland.

NEUROPATH 6Fx100 GUIDING CATH MP || Product Code: GMC61000000 || Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices

Lot Codes:  CLNCB1 CMBBP1 CMBCPN CMCBWG CMCC2V CMDCN8 CMDDJN CMGB8H CMJCL8 CMJCPW CMKB21 CMMCGR CMNBFB CMNBZJ CMNC8T CMNCYL CMPB4V CNCCPF CNDBCW CNDBRH CNDCJ2 CNFCK7 CNGBG0 CNGBK2 CNHCKH CNHCZN CNJBW5 CNJBWZ CNJC38 CNJC4K CNJCD3 CNJCFR CNJCMN CNKBWP CNKCC8 CNKCL3 CNLBR6 CNLCL3 CNLCW3 CNNCWF CNPB1R CNPBRH CNPCLR CPBC96 CPBCCR CPBCRV CPCBG9 CPCCMK CPDBYC CPDC07 CPDCC7 CNBBCV CNCB6W CNGBRY CNHB95 CNNDCK CNPB1T CNPBML CPBB3G CPCBG8 CPCCBH CPCCM1 CPCCMZ CPFBKP

Neurological Devices

2

Yes

Worldwide Distribution - US Nationwide, Australia, Austria, Belgium, Brazil, Switzerland, Czech Republic, Germany, Spain, Finland, France, Great Britain, Israel, Italy, Netherlands, Norway, Portugal, Russia, Saudi Arabia, Sweden, Slovenia, Slovakia, Turkey, South Africa, and UK.

Codman Certas Programmable Valve In Line Valve Only || Product Code: 82-8800 || Product Usage: || 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. The valve can be set to a choice of eight opening pressure settings for constant intraventricular perssure drainage of CSF. The CODMAN CERTAS Therapy Management System (TMS) allows the non-invasive reading or adjustment of the valve setting.

Lot Codes:  CMBBP2 CMCBLG CMDBHG CMFBB8 CMHDFW CMJCPY CMLBLW CMLCKP CMMBCY CMMC3F CMNBFC CMNCDW CMPB96 CNCCLK CNJBW0 CNJC4B CNJC4W CNKBWN CNKCL1 CNLBR3 CNLBZF CNMDM1 CNNCPL CNNDH4 CNPBRM CPBBGP CPBC97 CPBCRW CPCBHB CPCCMP CPDBYF CPBCVD CPDBYD  CPDBM1 CMBCB2 CMCBLH CMDBHF CMGBL5 CMJCMC CMLBLY CMNBZK CNDCV1 CNHC8N CNKB41 CNLBR5 CNMB2Z CNMDNN CNNCWG CNPB1Y CNPCLT CPBCRY CPFBK1  CLPCM9 CMBBB2 CMBBB3 CMDBHD CMDCN7 CMDDJT CMFBNK CMFBNL CMNBZG CNDCP3 CNGBK5 CNHCZP CNJB1F CNJC4R CNJCMP CNKB0Y CNLCL0 CNMCYY CNMDNJ CNNDH0 CNPBRK CNPCLW CPBBGR CPCCBC CPCCML CPDCC2

Neurological Devices

2

Yes

Worldwide Distribution - US Nationwide, Australia, Austria, Belgium, Brazil, Switzerland, Czech Republic, Germany, Spain, Finland, France, Great Britain, Israel, Italy, Netherlands, Norway, Portugal, Russia, Saudi Arabia, Sweden, Slovenia, Slovakia, Turkey, South Africa, and UK.

Codman Certas Programmable Valve In Line Valve with Catheter and Accessories || Product Code: 82-8801 || Product Usage: || 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. The valve can be set to a choice of eight opening pressure settings for constant intraventricular perssure drainage of CSF. The CODMAN CERTAS Therapy Management System (TMS) allows the non-invasive reading or adjustment of the valve setting.