Events

Rappel de Open & Unused Items - This refers to a sterilization service provided by by SterilMed, Inc. (devices were not reprocessed) for Class 1 and Class 2 devices that were opened, most likely in O. R. suites, in which for whatever reason the physician elected to select a different type of device, different size of device, or maybe elected to not use the device at all in a procedure. This is not a process regulated by FDA, but is included in the recall process as product would still be considered misbranded and or represent a potential risk to patients. || Model #'s: || ABB6543-01 || ABB6544-01 || ACM23116 || ACR800-499 || ACU014719 || ALL2N2704X || ALLASC1201 || ALLF-5501 || ALLSU130-404E || ARTAR-6530 || ARTAR-6540 || ARTAR-6560 || ARTAR-6562 || ARTAR-6564 || ARTAR-6570 || AUT054887 || AUT059035 || AUT059037 || AUT174001 || AUT8886803712 || AUTGIA6025S || BAL60417 || BAR0043620 || BAR0070740 || BAR0601110 || BAR072231 || BARBRD100R || BAX2C4005 || BER610 || BIO418200 || BIO631031 || BOUTC001NSKA || CARASU1510 || COD26-1221 || CON130309 || CON130321 || CON134006 || CON1412 || CON29410 || CON29415H || CON29496 || CON60-6085-100 || CON8535 || CON9413 || CON9448 || COO081012 || COO081014 || COOCTI-512N || COOTD-1 || COOZSI1151 || DAV0035280 || DAV0043650 || DEN50-7000 || DEN50-7500 || DER28-0211 || DLP10012 || EDWDSAFE61 || EDWFEMII016A || ETH10BB || ETH2189 || ETH2211 || ETH5BB || ETH6TB45 || ETHBTD05 || ETHPMW35 || ETHPRW35 || ETHPXW35 || ETHUV120 || FUT4549 || GUIOM-9000S || GUIXP-4000 || GYR240060 || GYR240072 || GYR70138000 || GYR7013-8100 || GYR70140257 || JOH2214 || KEN31140240 || KEN31140562 || KEN8884720221 || KEN8888505172 || KIM111 || KIM228 || kim279 || KIM311 || KIM330 || KIM345 || KIM70321 || KIM79043 || KIM79870 || KIM79878 || KIM888 || KIM89601 || KIM95111 || KIM95521 || KIR10-4000 || KIR10-4001 || KIR14-3000 || KRO6003 || LIN9718 || LINESA-5333 || LINESA-5339 || MECEPT03 || MED05897/JP2311 || MED10001S/JP10001 || MED11348/DYNJP2500 || MED14184/JP2414 || MED14184A/JP2414A || MED21394P/JP2302P || MED2457S/JP8303 || MED2505/JP2510 || MED3110A/JP3003A || MED3110S/JP3003 || MED3130S/JP3008 || MED3140S/JP3005 || MED3820A/JP3102A || MED3820S/JP3102 || MED4202S/JP4003 || MED6052-53 || MED8610S/JP8005 || MED91263 || MED96570-021 || MEDDYNJ01201H || MEDDYNJ05933 || MEDDYNJO5933 || MEDDYNJP8201 || MEDSPT-2314/JP2314HD || MEG0012 || MEG0020 || MEG0035H || MEG0039H || MIC390-310 || MIC6131 || MIC6237 || MIC670-308 || MIC710-111 || MIC81010 || MPS5001689 || OLS20-1410KI || ORSORS-300 || Q2M20-1370 || RMITF-3646-0 || SMI4116 || SMI4615 || SMI4616 || SMI71111579 || SMI7204727 || SMI72200195 || SPIXDWIK28 || STR1608-2-59 || STR1608-2-63 || STR206-16 || STR206-546 || STR250-070-530 || STR250-070-540 || STR275-802-000 || STR306-553 || STR350-202-000 || STR3910-075-500 || STR3910-075-501 || STR3910-075-650 || STR3910-075-651 || STR3910-075-800 || STR400-800 || STR501-140-50 || STR5120-103-15 || STR606-563 || STR620-030-301 || STR620-030-407 || STR620-30-301 || SYN55.36E || SYNSDLB || TELDP-40K || TELMDP-40K || TER5842 || TERL7328 || TEX311033-000 || USE00712031 || VALE1450-6 || VALE1510 || VALE2350H || VALE2450H || VALE2505-10FR || VALE2515H || VALE2516H || WAL909009 || WEC528235 || WEL24-6001 || XOM1014242 || XOM10-46001 || XOM1850200 || XOM31-55631 || XOM31-55632 || XOM31-55636 || XOM31-55637 || XOM31-55638 and || XOM8225825

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Sterilmed Inc.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    49510
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0574-2009
  • Date de mise en oeuvre de l'événement
    2008-08-08
  • Date de publication de l'événement
    2009-01-13
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-04-26
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73705
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Operating Room Accessories Table Tray - Product Code FWZ
  • Cause
    Sterimed, inc is conducting a product removal of a small group of devices individually packaged and sealed within a pouch. the removal is being conducted because the possibility exists that some of the pouches were not properly sealed on one end. a breach in packaging seal or a failure in packaging integrity has the possibility of risk to the patient in terms of transmitting organisms capable.
  • Action
    Consignees were notified of the recall via verbal communication in person by on-site technician and or their local sales representative on 8/8/08. Others were contacted via fax or e-mail followed by on-site visits 8/11/08. SteriMed also provided consignees (Materials Manager/Risk Manager) with a "Urgent Product Removal" recall letter (August 14, 2008) in person informing them of the potential of receiving affected product. Included in the Product Removal Notification was a Customer Reply Form to inventory quantity of product received and quantity returned. Contact SterilMed, Inc. at 1-888-541-0078 for assistance.

Device

Open & Unused Items - This refers to a sterilization service provided by by SterilMed, Inc. (dev...
  • Modèle / numéro de série
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    AL, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, MA, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, WA, WI, and WV OUS: CANADA
  • Description du dispositif
    Open & Unused Items - This refers to a sterilization service provided by by SterilMed, Inc. (devices were not reprocessed) for Class 1 and Class 2 devices that were opened, most likely in O. R. suites, in which for whatever reason the physician elected to select a different type of device, different size of device, or maybe elected to not use the device at all in a procedure. This is not a process regulated by FDA, but is included in the recall process as product would still be considered misbranded and or represent a potential risk to patients. || Model #'s: || ABB6543-01 || ABB6544-01 || ACM23116 || ACR800-499 || ACU014719 || ALL2N2704X || ALLASC1201 || ALLF-5501 || ALLSU130-404E || ARTAR-6530 || ARTAR-6540 || ARTAR-6560 || ARTAR-6562 || ARTAR-6564 || ARTAR-6570 || AUT054887 || AUT059035 || AUT059037 || AUT174001 || AUT8886803712 || AUTGIA6025S || BAL60417 || BAR0043620 || BAR0070740 || BAR0601110 || BAR072231 || BARBRD100R || BAX2C4005 || BER610 || BIO418200 || BIO631031 || BOUTC001NSKA || CARASU1510 || COD26-1221 || CON130309 || CON130321 || CON134006 || CON1412 || CON29410 || CON29415H || CON29496 || CON60-6085-100 || CON8535 || CON9413 || CON9448 || COO081012 || COO081014 || COOCTI-512N || COOTD-1 || COOZSI1151 || DAV0035280 || DAV0043650 || DEN50-7000 || DEN50-7500 || DER28-0211 || DLP10012 || EDWDSAFE61 || EDWFEMII016A || ETH10BB || ETH2189 || ETH2211 || ETH5BB || ETH6TB45 || ETHBTD05 || ETHPMW35 || ETHPRW35 || ETHPXW35 || ETHUV120 || FUT4549 || GUIOM-9000S || GUIXP-4000 || GYR240060 || GYR240072 || GYR70138000 || GYR7013-8100 || GYR70140257 || JOH2214 || KEN31140240 || KEN31140562 || KEN8884720221 || KEN8888505172 || KIM111 || KIM228 || kim279 || KIM311 || KIM330 || KIM345 || KIM70321 || KIM79043 || KIM79870 || KIM79878 || KIM888 || KIM89601 || KIM95111 || KIM95521 || KIR10-4000 || KIR10-4001 || KIR14-3000 || KRO6003 || LIN9718 || LINESA-5333 || LINESA-5339 || MECEPT03 || MED05897/JP2311 || MED10001S/JP10001 || MED11348/DYNJP2500 || MED14184/JP2414 || MED14184A/JP2414A || MED21394P/JP2302P || MED2457S/JP8303 || MED2505/JP2510 || MED3110A/JP3003A || MED3110S/JP3003 || MED3130S/JP3008 || MED3140S/JP3005 || MED3820A/JP3102A || MED3820S/JP3102 || MED4202S/JP4003 || MED6052-53 || MED8610S/JP8005 || MED91263 || MED96570-021 || MEDDYNJ01201H || MEDDYNJ05933 || MEDDYNJO5933 || MEDDYNJP8201 || MEDSPT-2314/JP2314HD || MEG0012 || MEG0020 || MEG0035H || MEG0039H || MIC390-310 || MIC6131 || MIC6237 || MIC670-308 || MIC710-111 || MIC81010 || MPS5001689 || OLS20-1410KI || ORSORS-300 || Q2M20-1370 || RMITF-3646-0 || SMI4116 || SMI4615 || SMI4616 || SMI71111579 || SMI7204727 || SMI72200195 || SPIXDWIK28 || STR1608-2-59 || STR1608-2-63 || STR206-16 || STR206-546 || STR250-070-530 || STR250-070-540 || STR275-802-000 || STR306-553 || STR350-202-000 || STR3910-075-500 || STR3910-075-501 || STR3910-075-650 || STR3910-075-651 || STR3910-075-800 || STR400-800 || STR501-140-50 || STR5120-103-15 || STR606-563 || STR620-030-301 || STR620-030-407 || STR620-30-301 || SYN55.36E || SYNSDLB || TELDP-40K || TELMDP-40K || TER5842 || TERL7328 || TEX311033-000 || USE00712031 || VALE1450-6 || VALE1510 || VALE2350H || VALE2450H || VALE2505-10FR || VALE2515H || VALE2516H || WAL909009 || WEC528235 || WEL24-6001 || XOM1014242 || XOM10-46001 || XOM1850200 || XOM31-55631 || XOM31-55632 || XOM31-55636 || XOM31-55637 || XOM31-55638 and || XOM8225825
  • Manufacturer
    Sterilmed Inc

Manufacturer

Sterilmed Inc
  • Adresse du fabricant
    Sterilmed Inc, 11400 73rd Ave N Ste 100, Osseo MN 55369-5562
  • Société-mère du fabricant (2017)
    Johnson & Johnson
  • Source
    USFDA