Events

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 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Sterilmed Inc 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    49510
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0574-2009
  • 사례 시작날짜
    2008-08-08
  • 사례 출판 날짜
    2009-01-13
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-04-26
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73705
  • 비고 / 경고
    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.
  • 데이터 추가 비고
    Operating Room Accessories Table Tray - Product Code FWZ
  • 원인
    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.
  • 조치
    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...
  • 모델명 / 제조번호(시리얼번호)
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    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
  • 제품 설명
    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
  • 제조사 주소
    Sterilmed Inc, 11400 73rd Ave N Ste 100, Osseo MN 55369-5562
  • 제조사 모회사 (2017)
    Johnson & Johnson
  • Source
    USFDA