FDA Device Recall Z-0028-2009: Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0028-2009.

Recall Res Number

Z-0028-2009

Recalling Firm / Manufacturer

Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa

FEI Number

2027111

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2008-06-25

Date Posted

2008-10-07

Date Terminated

2012-03-26

Product Code

GCJ

Event Number

49445

Product Quantity

14,113 total

Product Description Applied Medical, Lap Banding Kit, REF: K0406 Contains: (1) C0658, 11x100mm Threaded Shielded Trocar w/Universal Seal (1) C0522, 5x100mm Threaded Premium Flat Blade (1) C2202, 150mm Insufflation needle (1) C0605, 15x100mm Threaded Separator Access System (1) CB030, 5mm x 35cm Direct Drive Disposable Scissors (2) C4120, 5mm x 38cm Direct Drive Grasper Reposable Cartridge, for laparoscopic procedures.

Reason for Recall Potential inability to insufflate through the stopcock. Under certain circumstances, a flexible elastomeric component inside the 15mm trocar can stretch into a configuration that blocks the flow of insufflation gas (C02).

Action Details Customers were notified via FedEx or UPS on June 25,2008 with an overnight letter. The letter advises that Applied Medical is conducting a voluntary recall of the 15mm Separator Access Systems, Models C0604, C0605, C0606 and C0607 due to the potential inability to insufflate through the stopcock. Per the letter, the firm is asking that all 15mm product listed in the letter be returned. A response form is provided.

Distribution Pattern Nationwide and Canada distribution.

Code Information / Serial Numbers Product/Kit Batch Numbers: 1059718, 1060488, 1061516, 1062296, 1063810

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VIETMEDICAL DISTRIBUTION JOINT STOCK COMPANY Registration: 3016727307 View Registration
CLEARCAM Registration: 3016804805 View Registration
Arthrex Distribution Hub EMEA B.V. Registration: 3016851379 View Registration
ETHICON, INC. Registration: 3017102971 View Registration
Intuitive Surgical Optics GmbH Registration: 3017119401 View Registration
BRDH Registration: 3017196117 View Registration
VOMA ECZA DEPOSU MEDIKAL URUNLER SAN. TIC. A.S. Registration: 3017210488 View Registration
Wuxi Goals Medical Technology Co., Ltd. Registration: 3017262662 View Registration
INCORE CO., LTD. Registration: 3017390965 View Registration
STERIS Corporation de Republica Dominicana, S.R.L. Registration: 3017636737 View Registration
Medtronic Engineering and Innovation Center (MEIC) Registration: 3018094310 View Registration
Intuitive Surgical, Inc. Registration: 3018126215 View Registration
M&L PRECISION MACHINING INC. Registration: 3018907196 View Registration
KRONNER PROTOTYPES, INC. Registration: 3018984 View Registration
Arthrex Australia Pty Ltd. Registration: 3019269298 View Registration
OMEC MEDICAL NV INC Registration: 3020142503 View Registration
SHANGHAI LEJOY CO., LTD Registration: 3020468145 View Registration
PIXEE MEDICAL Registration: 3020703212 View Registration
Arthrex New Zealand Limited Registration: 3020704423 View Registration
SCIVITA MEDICAL TECHNOLOGY CO., LTD. Registration: 3020746799 View Registration
Transmedic Philippines Inc. Registration: 3020899789 View Registration
Springboard Manufacturing Registration: 3021140368 View Registration
Arthrex Colombia SAS Registration: 3021226419 View Registration
BIOCELLS DISCOVERIES INTERNACIONAL (BIOCELLS) Registration: 3021336182 View Registration
Activ Surgical Inc Registration: 3021336392 View Registration
COMHUGE MEDICAL WIRE AND HARNESS TECHNOLOGY CO., LTD Registration: 3021355451 View Registration
BIOGENOMICS S.A.C. - BIOCELLS SURGICAL Registration: 3021393544 View Registration
IVUS ILAC SANAYI VE TICARET AS Registration: 3021632375 View Registration
Lazurite Inc. Registration: 3021744308 View Registration
VPIX MEDICAL, INC. Registration: 3021744379 View Registration
FREYJA HEALTHCARE, LLC Registration: 3021875817 View Registration
Intuitive Surgical, Inc. Registration: 3022626486 View Registration
Hipp Medical AG Registration: 3023852420 View Registration
MDTGLOBAL, A.S. Registration: 3024021261 View Registration
Barco (Suzhou) Healthcare Technology Co., Ltd. Registration: 3024137003 View Registration
PLASMATICA Registration: 3025306172 View Registration
JR-MEDIZINTECHNIK GMBH & CO KG Registration: 3025482817 View Registration
ARK SURGICAL Registration: 3025598220 View Registration
BIOTEC BIOTECNOLOGIAS DE CENTROAMERICA S.A. Registration: 3027242374 View Registration
Arthrex Chile SPA Registration: 3027339877 View Registration
XPAN INC. Registration: 3027500817 View Registration
SHENZHEN JINGXINTAI HOUSEWARE CO., LTD Registration: 3029950834 View Registration
GUANGDONG OPTOMEDIC TECHNOLOGIES, INC. Registration: 3029968414 View Registration
Stryker Sustainability Solutions - Chandler Registration: 3030153385 View Registration
Altek Medical Sdn. Bhd. Registration: 3030311186 View Registration
PHARMCO MEDICAL BV Registration: 3030447506 View Registration
HUNAN ENDOSO LIFE TECHNOLOGY CO., LTD Registration: 3030504644 View Registration
PALM MEDICAL INTERNATIONAL BV Registration: 3030626857 View Registration
AD SUPPLY GROUP LIMITED Registration: 3030733800 View Registration
HANGZHOU ENDO MEDICAL INSTRUMENT CO.,LTD Registration: 3030839824 View Registration
Arthrex Logistic Center Canada Registration: 3030926959 View Registration
Arthrex Medical Device (Shanghai) Co. Ltd. Registration: 3031238646 View Registration
MEDCARE SOLUTIONS GMBH Registration: 3031240334 View Registration
ZHUHAI DIPU MEDICAL TECHNOLOGY CO., LTD. Registration: 3031594238 View Registration
Medline ReNewal Registration: 3032391 View Registration
NOVANTA MEDICAL S.R.O. Registration: 3033043422 View Registration
OMEC THAI CO.,LTD. Registration: 3033902430 View Registration
Zimmer Biomet Pty Ltd Registration: 3035366890 View Registration
MED2B LTD. Registration: 3035708926 View Registration
MAYA MEDICAL TOP TRADE LTD. Registration: 3036773433 View Registration
Intuitive Surgical Optics GmbH Registration: 3038187466 View Registration
Intuitive Surgical Bulgaria EOOD Registration: 3038188839 View Registration
FUJIFILM Corporation Medical Systems Research & Development Center Kaisei Registration: 3042225166 View Registration
Intuitive Solutions Registration: 3042953929 View Registration
SHENZHEN SOPHWAY TECHNOLOGY CO., LTD. Registration: 3043152784 View Registration
SICHUAN INNOVATION TECHNOLOGY CO., LTD. Registration: 3043225236 View Registration
ZAPALIGN LLC Registration: 3043226252 View Registration
SCOPIX Registration: 3044828322 View Registration
TERUMO CORP. Registration: 8010026 View Registration
OLYMPUS MEDICAL SYSTEMS CORP. Registration: 8010047 View Registration
GEOMED MEDIZIN-TECHNIK GMBH & CO. KG Registration: 8010168 View Registration
HERMANN MEDIZINTECHNIK GMBH Registration: 8010257 View Registration
ACKERMANN INSTRUMENTE GMBH Registration: 8010273 View Registration
RUDOLF MEDICAL GMBH + CO. KG Registration: 8010298 View Registration
VOMED VOLZER MEDIZINTECHNIK GMBH & CO.KG Registration: 8010349 View Registration
GUENTER STOFFEL MEDIZINTECHNIK GMBH Registration: 8010370 View Registration
Instrumed GmbH dba Avalign German Specialty Instruments Registration: 8010372 View Registration
HENKE-SASS WOLF, GMBH. Registration: 8010418 View Registration
MAX HAUSER SUDDEUTSCHE CHIRURGIEMECHANIK GMBH Registration: 8010422 View Registration
GUENTER BISSINGER MEDIZINTECHNIK GMBH Registration: 8010456 View Registration
BACHER MEDIZINTECHNIK GMBH Registration: 8010487 View Registration
Strub Medical GmbH & Co. KG Registration: 8010510 View Registration
Faulhaber Pinzetten KG Registration: 8010591 View Registration
GEISTER MEDIZINTECHNIK GMBH Registration: 8010697 View Registration
SMI MEDICAL INSTRUMENTS GMBH & CO.KG Registration: 8010871 View Registration
KOSCHER & WUERTZ GMBH Registration: 8010877 View Registration
medi-plus Instrumente GmbH Registration: 8010935 View Registration
Canadian Hospital Specialties Ltd. Registration: 8022210 View Registration
Industrias Apson S.A de C.V Registration: 8030607 View Registration
QSA SURGICAL (PVT) LTD. Registration: 8040233 View Registration
MODERN MEDICAL EQUIPMENT MANUFACTURING, LTD. Registration: 8040510 View Registration
SHENZHEN JPY ION-TECH. CO., LTD. Registration: 8043396 View Registration
BAK KOHLER Medical KG Registration: 8043548 View Registration
TROKAMED GMBH Registration: 8043746 View Registration
SCHOELLY FIBEROPTIC, GMBH Registration: 8043903 View Registration
T.A.G. MEDICAL PRODUCTS CORPORATION LTD Registration: 8043971 View Registration
Novanta Medical GmbH Registration: 8043980 View Registration
Vitalitec International Medizintechnik GmbH Registration: 8044057 View Registration
HGR INSTRUMENTE GMBH Registration: 8044098 View Registration
XION GmbH Registration: 9515015 View Registration
AIZU OLYMPUS CO., LTD. Registration: 9610595 View Registration
AESCULAP AG Registration: 9610612 View Registration
KARL STORZ SE & CO. KG Registration: 9610617 View Registration
OLYMPUS WINTER & IBE GMBH Registration: 9610773 View Registration
RICHARD WOLF GMBH Registration: 9611102 View Registration
HEBUMEDICAL GMBH Registration: 9611112 View Registration
RUDOLF STORZ GMBH Registration: 9611274 View Registration
KARL KLAPPENECKER GMBH & CO. KG Registration: 9611281 View Registration
TEKNO MEDICAL OPTIK-CHIRURGIE GMBH Registration: 9611503 View Registration
AVENT S. de R.L. de C.V. Registration: 9611594 View Registration
PAJUNK GMBH MEDIZINTECHNOLOGIE Registration: 9611612 View Registration
Sterigenics EO Canada, Inc. Registration: 9611665 View Registration
ERCHINGER AG Registration: 9611827 View Registration
Cardinal Health (Kenmex Medical Specialties) Registration: 9612030 View Registration
GIMMI GMBH Registration: 9612074 View Registration
OERTEL MEDICAL GMBH Registration: 9612075 View Registration
B. BRAUN MEDICAL INDUSTRIES SDN. BHD. Registration: 9612086 View Registration
DUFNER INSTRUMENTE GMBH Registration: 9612278 View Registration
Covidien Registration: 9612501 View Registration
BARCO N.V. Registration: 9613188 View Registration
DEROYAL CIENTIFICA DE LATINOAMERICA S.R.L. Registration: 9613793 View Registration
NOVATECH S.A. Registration: 9613846 View Registration
Corin Limited Registration: 9614209 View Registration
STORZ ENDOSKOP PRODUKTIONS GMBH Registration: 9614434 View Registration
AOMORI OLYMPUS CO., LTD. Kuroishi Site Registration: 9614641 View Registration
ROMINGER MEDIZINTECHNIK GMBH Registration: 9614945 View Registration
BOWA-ELECTRONIC GMBH & CO. KG Registration: 9614969 View Registration
SOPRO Registration: 9615782 View Registration
DAVOL SURGICAL INNOVATIONS Registration: 9616067 View Registration
Convertors de Mexico S. de R.L. de C.V Registration: 9616088 View Registration
Sterigenics S. de R.L. de C.V. Registration: 9616517 View Registration
ICU Medical Healthcare Manufacturing S.A. de C.V. Registration: 9616567 View Registration
Venusa de Mexico S. de R.L de C.V Registration: 9680001 View Registration
TONTARRA MEDIZINTECHNIK GMBH Registration: 9680515 View Registration
RZ MEDIZINTECHNIK GMBH Registration: 9680718 View Registration
MODERN MEDICAL EQUIPMENT MANUFACTURING LTD. Registration: 9680721 View Registration
INTEGRA MICROFRANCE SAS Registration: 9680837 View Registration
SURGICAL INNOVATIONS LTD Registration: 9680952 View Registration
BEMA-GMBH & CO. KG Registration: 9681129 View Registration
GLASER AG Registration: 9681147 View Registration
NEW DEANTRONICS TAIWAN LTD. Registration: 9681191 View Registration
Boston Scientific Limited Registration: 9681260 View Registration
ASHITAKA FACTORY OF TERUMO CORP. Registration: 9681834 View Registration
JR MONTAGEARBEITEN Registration: 9710058 View Registration
ULTIMATE MEDICAL PRODUCTS LTD. Registration: 9710524 View Registration
ETHICON ENDO-SURGERY S.A. DE C.V. PLANTA II Registration: 9710649 View Registration

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This page represents an index of public-record FDA device recalls. It does not imply current safety or compliance status of the product. AvaSpecs is a private aggregator and is not affiliated with the FDA or any government agency. This page does not constitute medical, safety, legal, regulatory, or compliance advice. Refer to official government sources for primary safety alerts.

Medical Device Recall: Z-0028-2009

Recall Parameters & Description

Related Establishments / Registrations

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