Ad-Tech Medical Instrument Corporation Issues Global Recall of Macro Micro Subdural Electrodes
Thursday, 28 February 2013 09:55
Consumer
This e-mail address is being protected from spambots. You need JavaScript enabled to view it
1-800-776-1555
Media
Lisa Theama
262-634-1555
www.adtechmedical.com
FOR IMMEDIATE RELEASE - February 28, 2013 - On December 18, 2012 Ad-Tech Medical Instrument Corporation initiated a recall of 115 Macro Micro Subdural Electrodes. There is a concern the microelectrodes are not flush with the silastic surface. As a result, there is the potential for abrasion of cortical brain tissue and the existence of fractured pieces remaining in the cortical tissue when the electrode is explanted, which may result in hemorrhage or damage to cortical fibers, leading to infarct or seizure activity.
Recalled Product(s) were manufactured from June 2006 to March 2012, and distributed from June 8, 2006 to March 14, 2012.
The following Macro Micro Subdural Electrodes have been recalled:
CATALOG NUMBERS | LOT NUMBER | BATCH | QTY |
QGC8A-SP10N-OOO | G608060002 | 0020161 | 1 |
QGC8D-SP10N-OOO | C704040001 | 0025418 | 1 |
QGC8A-SP10N-OOO | G704150001 | 0026119 | 1 |
QGC8A-SP10N-OOO | C703160006 | 0026358 | 2 |
EGE4A-SP10N-OOO | C702201001 | 0029304 |
1 |
QGC8A-SP10N-OOO | C805210003 | 0030815 | 1 |
QG36A-SP10N-000 | C805210004 | 0030819 | 2 |
QG36A-SP10N-OOO | C802220003 | 0031061 | 1 |
QGC8A-SP10N-OOO | C802220005 | 0031035 | 1 |
EGE4A-SP10N-OOO | C802220006 | 0031104 | 2 |
EGE4A-SP10N-OOO | C801240003 | 0032308 | 2 |
EGE4A-SP10N-OOO | C800250002 | 0033276 | 1 |
EGE4A-SP10N-OOO | C800350004 | 0033277 | 1 |
EGE4A-SP10N-OOO | G805270001 | 0034692 | 1 |
QGC8B-SP10X-OOO | 208140314 | 0038610 | 1 |
EGE4A-SP10X-OOO | 208140314 | 0038520 | 3 |
QGC8A-SP10N-OOO | G903080003 | 0041526 | 1 |
QG36A-SP10N-OOO | 5903080004 | 0041659 | 1 |
QS20A-SP10N-OOO | 5905280003 | 0042295 | 1 |
QGC8C-SP10X-OOO | 208140343 | 0043004 | 1 |
QGC8B-SP10X-OOO | 208140344 | 0043076 | 1 |
EGD7A-MP12N-OOO | G903011001 | 0043905 | 1 |
EGD7A-MP12N-OOO | G900211002 | 0044215 | 1 |
QG18A-SP10N-OOO | C908221002 | 0044840 | 2 |
QG16A-SP10X-OOO | 208140353 | 0044772 | 2 |
QG18A-SP10X-OOO | 208140353 | 0044835 | 2 |
QGC8B-SP10X-OOO | 208140354 | 0044932 | 1 |
QGC8A-SP10N-OOO | G015020002 | 0045573 | 1 |
QG20B-SP10N-OOO | 019020 | 0045227 | 3 |
QG53A-SP10X-OOO | 208140362 | 0046112 | 1 |
QG96A-SP10N-OOO | G012140002 | 0047160 | 1 |
QG66A-SP85N-OOO | G016240001 | 0047248 | 1 |
QG96A-SP10X-OOO | 208140369 | 0047159 | 1 |
QGC8D-SP10N-OOO | G019150003 | 0048115 | 1 |
QG26A-SP10N-OOO | G017250004 | 0048221 | 1 |
QG36B-SP10N-OOO | G0172S0005 | 0048224 | 1 |
EG10A-SP10N-OOO | G017250006 | 0048181 | 1 |
QG96A-SP10X-OOO | 208140374 | 0047724 | 1 |
EG34B-SP10X-OOO | 208140381 | 0048753 | 1 |
QG20E-SP10X-OOO | 208140382 | 0048898 | 1 |
QG20D-SP10X-200 | 208140382 | 0048899 | 1 |
QGC8E-SP10X-OOO | 208140382 | 0048901 | 1 |
QG36A-SP10N-OOO | C010180001 | 0050030 | 2 |
QG36A-SP10X-OOO | 208140387 | 0050031 | 2 |
QG17A-SP10X-OOO | 208140390 | 0050218 | 1 |
QG18A-SP10X-OOO | 208140395 | 0051090 | 2 |
QG20F-SP10X-OOO | 208140398 | 0051181 | 1 |
QG10B-SP10X-OOO | 208140398 | 0051442 | 1 |
QG18A-SP10N-OOO |
G012111001 | 0051906 |
1 |
QG18A-SP10N-OOO | G018011001 | 0051663 | 1 |
QG10C-SP10N-OOO | G018011003 | 0051667 | 2 |
QG10D-SP10N-OOO | G018011002 | 0051675 | 2 |
QG11A-SP10X-OOO | 208140399 | 0051598 | 2 |
QG10C-SP10N-OOO | G019021002 | 0052519 | 2 |
QG10D-SP10N-OOO | G019021003 | 0052260 | 2 |
QGC8B-SP10X-OOO | 208140356R | 0044932 | 1 |
QGC6A-SP07N-OOO | G119020004 | 0053503 | 1 |
QG20B-SP10X-OOO | 208140357R | 0045319 | 1 |
QG16A-SP10X-OOO | 208140414 | 0054443 | 3 |
QG16A-SP10X-OOO | 208140417 | 0055275 | 1 |
QGC8F-SP10X-OOO | 208140421 | 0055934 | 1 |
QG36A-SP10N-OOO | G114160002 | 0056510 | 1 |
QG10C-SP10N-OOO | G114160001 | 0056441 | 1 |
QG36A-SP10N-OOO | G115170004 | 0057159 | 1 |
QG20C-SP10N-OOO | G112270004 | 0057110 | 2 |
QG96C-SP10X-OOO | 208140431 | 0057422 | 1 |
QS40B-SP10X-OOO | 208140431 | 0057284 | 1 |
QG36A-SP10N-OOO | G115080002 | 0057839 | 1 |
QG24A-SP10N-OOO | G115280005 | 0058246 | 2 |
QG20B-SP10X-OOO | 208140357R | 0045319 | 1 |
QG20B-SP10X-OOO | 208140357R | 0045319 | 1 |
QG20C-SP10X-OOO | 208140443 | 0059392 | 1 |
QGC8A-SP10X-OOO | 208140443 | 0059234 | 1 |
QG18A-SP10X-OOO | 208140443 | 0059248 | 1 |
QG11A-SP10X-OOO | 208140445 | 0059777 | 1 |
QG32A-SP10X-OOO | 208140450 | 0060750 | 1 |
QG32B-SP10X-OOO | 208140450 | 0060751 | 2 |
QG96C-SP10X-OOO | 208140450 | 0060500 | 1 |
QG96D-SP10X-OOO | 208140450 | 0060740 | 2 |
QG16A-SP10X-OOO | 208140452 | 0060830 | 2 |
QG18A-SP10X-OOO | 208140452 | 0060879 | 2 |
QG88A-SP10X-OOO | 208140452R | 0060885 | 1 |
QG44A-SP10X-OOO | 208140453 | 0061307 | 2 |
QG69A-SP10N-OOO | G211220001 | 0062673 | 1 |
QG36A-SP10X-OOO | 208140450 | 0059620 | 2 |
QG36A-SP10X-OOO | 208140458 | 0061050 | 1 |
Product(s) can be identified by the label provided on the packaging.
Ad-Tech Medical Instrument Corporation voluntarily recalled the Macro Micro Subdural Electrodes after becoming aware of potential harm to the patient. Ad-Tech Medical Instrument Corporation has notified the FDA of this action.
There has been one reported serious injury that may have been related to the use of the device.
Ad-Tech Medical Instrument Corporation has notified its distributors and customers by Recall Letter and is arranging for the return of all available recalled product(s).
Ad-Tech Medical Instrument Corporation distributed product(s) to Hospitals and distributors in the United States, and internationally.
Customers with questions may contact the company via telephone at 1-800-776-1555 between the hours of 9:00-5:00 (Central Time). Customers may also contact the company via e-mail at This e-mail address is being protected from spambots. You need JavaScript enabled to view it .
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA:
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