Device Recall Weck

  • 모델명 / 제조번호(시리얼번호)
    Product manufactured from January 2006 through July 2008; (Product Description: HOL SMALL CLIPS 1 PACK, Product Code: 544210, Lot number: 01C0800150, and T1278089; Product Description: HOL SMALL CLIPS 4 PACK, Product Code: 544214, Lot number: T1278090, and T1278091; Product Description: HOL SMX CLIPS, Product Code: 544220, Lot number: 01D0800096, 01D0800274, 01M0700186, T1199965, T1203687, T1217534, T1228540, T1238491, T1240322, T1250508, T1254468, T1260331, T1261800, T1264120, T1264930, T1266953, T1271002, T1275103, and T1279909; Product Description: HOL ML CLIPS, Product Code: 544230, Lot number: 01A0800008, 01A0800061, 01A0800062, 01A0800177, 01A0800233, 01A0800344, 01A0800435, 01B0800174, 01B0800293, 01B0800374, 01C0800060, 01C0800149, 01C0800302, 01D0800094, 01D0800136, 01D0800275, 01E0800079, 01E0800112, 01E0800159, 01E0800249, 01E0800334, 01F0800022, 01F0800117, 01K0700006, 01K0700119, 01M0700014, 01M0700147, T1202230, T1202965, T1203688, T1213241, T1214808, T1218508, T1220366, T1222324, T1225867, T1226767, T1228410, T1228561, T1229915, T1230518, T1231590, T1232367, T1233411 , T1234215, T1235422, T1237016, T1238490, T1239528, T1244679, T1246346, T1246459, T1247429, T1249597, T1252218, T1252509, T1253546, T1254469, T1256202, T1256393, T1257303, T1258318, T1259122, T1261014, T1261801, T1262898, T1264221, T1264931, T1266150, T1266151, T1266954, T1268393, T1272013, T1272014, T1273718, T1276889, T1276890, T1277330, T1278118, T1279067, and T1279910; Product Description: HOL L CLIPS, Product Code: 544240, Lot number: 01A0800007, 01A0800094, 01A0800139, 01A0800188, 01A0800234, 01A0800318, 01A0800382, 01A0800383, 01B0800040, 01B0800047, 01B0800048, 01B0800116, 01B0800130, 01B0800205, 01B0800206, 01B0800331, 01C0800007, 01C0800008, 01C0800076, 01C0800107, 01C0800184, 01C0800254, 01D0800001, 01D0800002, 01D0800111, 01D0800198, 01D0800199, 01D0800277, 01D0800329, 01E0800009, 01E0800057, 01E0800058, 01E0800160, 01E0800161, 01E0800250, 01E0800251, 01E0800296, 01E0800353, 01E0800416, 01E0800417, 01F0800037, 01K0700008, 01K0700120, 01K0700272, 01L0700021, 01L0700107, 01L0700190, 01L0700271, 01M0700098, 01M0700126, and 01M0700148; Product Description: HOL XL CLIPS (EXTRA LARGE), Product Code: 544250, Lot number: 01A0800436, 01B0800082, 01B0800175, 01B0800294, 01B0800375, 01C0800255, 01C0800304, 01D0800141, 01E0800252, 01E0800352, 01K0700209, 01K0700310, 01L0700022, 01L0700191, 01L0700268, T1195768, T1202966, T1203690, T1208603, T1210246, T1211617, T1216058, T1221102, T1223849, T1226768, T1227722, T1228562, T1229917, T1230520, T1231592, T1232369, T1233413, T1234217, T1235424, T1236592, T1237531, T1238493, T1240323, T1244680, T1246541, T1247431, T1249598, T1250510, T1251534, T1252511, T1253547, T1256395, T1257305, T1258320, T1259124, T1261803, T1262822, T1262900, T1266956, T1268394, T1269024, T1270229, T1271005, T1273225, T1273797, T1275793, T1276892, T1277331, T1278121, and T1279068
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide
  • 제품 설명
    WECK Hem-o-lok¿¿ Non-absorbable Polymer Ligation Clips, Rx Only, Sterile, Teleflex Medical, RTC, NC 27709. The use of the reusable Teleflex Medical metal ligating clips is transient, invasive and intended for the application of hemostatic clips during general open surgery. Ligation clips are non-absorbable to thermostatically restrict flow of fluids within vessels. Clips are removed from the cartridge and applied in such a manner as to engulf vessels. Teleflex Medical metal ligating clips are intended for use in procedures involving vessels or anatomic structures for which the surgeon determines ligating clips are the best choice. Surgeons should select the size type, and material of the clip based upon their experience, judgment and needs.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Telefelx Medical, 2917 Weck Drive, Durham NC 27709
  • 제조사 모회사 (2017)
  • Source
    USFDA

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 27 건

데이터에 대해 더 자세히 알아보기 여기

  • 모델명 / 제조번호(시리얼번호)
    Product Code: 523300, Lot number: 01B1400034
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    US (nationwide) including the states of AL, CA, FL, DE, IA, IL, IN, KY, MA, MN, NC, NE, NJ, NY, NV, OH, OK, PA, TX, VA, VT, and WA.
  • 제품 설명
    WECK Hemoclip¿ Traditional Medium Tantalum Ligating Clips. || Weck Ligating Clips are intended for use in procedures involving vessels or anatomic structures for which the surgeon determines ligating clips are the best choice.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Product Code EFXCT1 - Lot/Batch Nos. ML-000342, ML-000343, ML-000344, ML-000348, ML-000349; Product Code EFXSP1 - Lot/Batch Nos. ML-000345, ML-000347
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution to CA, CO, IA, KS, MD, MI, NY, NC, PA
  • 제품 설명
    Weck EFx Classic Fascial Closure System, Rx Only, Sterile, || The product is intended to facilitate placement and withdrawal of suture loops to repair port side defects following laparoscopic surgery
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Product Code: 337111, Lot Number: 06F1515745.
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution US Nationwide in the states of FL, IL, KY, MI, NY and OK and countries of Mexico and Canada.
  • 제품 설명
    WECK¿ Horizon" Manual-Load Ligating Clip Applier, For Medium-Large Size Horizon Ligation Clips Curved Jaw, 11 (28cm), Rx Only, REF 337111, || Product Usage: Weck Closure Systems applier has been designed and calibrated for use with specific Horizon, Hemoclip Plus Hemoclip Traditional, or Atrauclip ligating clips as indicated. Applier color coding matches the color of the ligating clip cartridge for which it is to be used. Hemoclip Plus appliers are easily identified by one black-ring handle.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Product Code: EFX002, Lot numbers: 3264480000, 3269990000, 3270100000.
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Domestic; US Nationwide; International: Belgium, Canada.
  • 제품 설명
    Weck Facial Closure Systems have application in laparoscopic procedures for approximation of tissues and percutaneous suturing for closing incision sites.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Product Code: 528235, Lot numbers: 73C1600693, 73G1500681, 73H1500255, 73H1500256, 73K1500618, 73L1400006 and 73M1500130.
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution- U.S. (Nationwide) and countries of: Australia, Belgium, Canada, China, Germany, Hong Kong, India, Japan, Korea, Malaysia, New Zealand, Singapore and Thailand.
  • 제품 설명
    WECK Visistat 35W, Disposable Skin Stapler, Rx Only, Sterile, Teleflex Medical, NC 27709. || The intended use of the Visistat stapler is to close lacerations on the outer layer of the dermis for a wide range of general, thoracic, obstetric, gynecological, orthopedic, cardiovascular, urological, and plastic surgical procedures.
  • Manufacturer
하나 더 22 건 더