Food Recalls (FDA)

Ad-Tech Medical Instrument Corporation Issues Global Recall of Macro Micro Subdural Electrodes

Published on Thursday, 28 February 2013 17:55

FG_AUTHORS: FDA

Recall -- Firm Press Release FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company. Ad-Tech Medical Instrument Corporation Issues Global Recall of Macro Micro Subdural Electrodes Contact
Consumer
customersupport@adtechmedical.com
1-800-776-1555

Media
Lisa Theama
262-634-1555
www.adtechmedical.com

disclaimer icon 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
NUMBER

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
0031094

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
0038521
0038522

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
0060878

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 customersupport@adtechmedical.com.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA:

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