【转】FDA发布气管切开插管一级召回令
FDA发布气管切开插管一级召回令2012年2月25日，FDA发布一项有关气管切开插管的一级召回令，这是FDA最高级别的召回令，意味着有患者可能会因此受伤或死亡。
FDA公布这些插管的生产商为英国Smiths医疗国际有限公司，注册商标为Bivona（点击查看涉事插管的产品批次）。有报告称在移除这些涉事插管附件时，需要额外加力，有时甚至无法拔出，这有可能会导致患者受伤或死亡。在某些情况下，用力拔出插管时，会导致松脱现象。此时患者往往需要紧急更换插管。
FDA表示使用者需要鉴别目前正在使用的插管，避免使用涉事插管并更换为未受影响的产品。通常情况下，这些产品常在卫生保健结构或家庭中使用。
Trach Tube Recall Raised to Highest Level
FDA发布一项有关气管切开插管的一级召回令，这是FDA最高级别的召回令，意味着有患者可能会因此受伤或死亡。该产品不知在中国有销售多少？
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.
Smiths Medical Issues Urgent Device Recall
of Certain Bivona® Neonatal, Pediatric,
and Flextend Tracheostomy
Tubes
Contact:
Consumer:
866-216-8806
bivona.tr3@smiths-medical.com
Media:
Judith Rossi
Smiths Medical
781-792-2539FOR IMMEDIATE RELEASE - December 22, 2011 - Smiths Medical, a leading global medical device manufacturer, announced today that it is initiating a nationwide voluntary recall of Bivona® Neonatal, Pediatric and FlexTend™ Tracheostomy Tubes with integrated connector which is not designed to be used with a disconnect wedge. The FDA has been apprised of this action.Smiths Medical is conducting this recall because some customers have experienced difficulty disconnecting accessories from the connectors of the Affected Tubes. In some cases, the customer was unable to disconnect the accessory or excessive force led to decannulation of the tube, and an emergency tracheostomy tube change was required. If the accessory is correctly connected to the Affected Tubes, then there will be no issue with disconnection. A copy of the customer notification letter, along with pictures to distinguish the affected tubes, is posted on the Smiths Medical website at http://www.smiths-medical.com.Consumers who have the Affected Tubes should:
[*]Identify all affected unused product in inventory and segregate it to a quarantine location.
Complete the Confirmation Form located at http://www.smiths-medical.com1 and return it by Fax to 219-989-7259 or by email to bivona.tr3@smiths-medical.com. [*]Upon receipt of your completed Confirmation Form, Customer Service will contact you with a Return Material Authorization Number (RMA#), and will schedule the shipment of a replacement Bivona® Neonatal, Pediatric and FlexTend™ Tracheostomy Tube. If you are opting to return the product, credit will be issued upon receipt of the returned product.
If an Affected Tube is currently in use with a patient, there is no evidence to suggest that immediate removal of the Tracheostomy Tube is necessary. Please visit Smiths Medical’s website at http://www.smiths-medical.com/education-resources/videos/airway/index.html2 for a video demonstration on how to properly connect and disconnect accessories from the Affected Tubes.Details of Affected Devices:
Bivona® Neonatal, Pediatric and FlexTend™ Tracheostomy Tubes
Lot Numbers 1631477 through 1923406
Reorder Numbers
Reorder NumberProduct NameSize
60NFP40Bivona® Uncuffed Neonatal FlexTend™ Plus Tracheostomy Tube4.5
60NFPS25Bivona® Uncuffed Neonatal FlexTend™ Plus Tracheostomy Tube2.5
60NFPS30Bivona® Uncuffed Neonatal FlexTend™ Plus Tracheostomy Tube3.0
60NFPS35Bivona® Uncuffed Neonatal FlexTend™ Plus Tracheostomy Tube3.5
60NFPS40Bivona® Uncuffed Neonatal FlexTend™ Plus Tracheostomy Tube4.0
60P025Bivona® Uncuffed Pediatric Tracheostomy Tube2.5
60P030Bivona® Uncuffed Pediatric Tracheostomy Tube3.0
60P035Bivona® Uncuffed Pediatric Tracheostomy Tube3.5
60P040Bivona® Uncuffed Pediatric Tracheostomy Tube4.0
60P045Bivona® Uncuffed Pediatric Tracheostomy Tube4.5
60P050Bivona® Uncuffed Pediatric Tracheostomy Tube5.0
60P055Bivona® Uncuffed Pediatric Tracheostomy Tube5.5
60PFP40Bivona® Uncuffed Pediatric FlexTend™ Plus Extra Length Tracheostomy Tube4.0
60PFP45Bivona® Uncuffed Pediatric FlexTend™ Plus Extra Length Tracheostomy Tube4.5
60PFP50Bivona® Uncuffed Pediatric FlexTend™ Plus Extra Length Tracheostomy Tube5.0
60PFP55Bivona® Uncuffed Pediatric FlexTend™ Plus Extra Length Tracheostomy Tube5.5
60PFP60Bivona® Uncuffed Pediatric FlexTend™ Plus Extra Length Tracheostomy Tube6.0
60PFPS40Bivona® Uncuffed Pediatric FlexTend™ Plus Extra Length Tracheostomy Tube4.0
60PFPS45Bivona® Uncuffed Pediatric FlexTend™ Plus Extra Length Tracheostomy Tube4.5
60PFPS50Bivona® Uncuffed Pediatric FlexTend™ Plus Extra Length Tracheostomy Tube5.0
60PFPS55Bivona® Uncuffed Pediatric FlexTend™ Plus Extra Length Tracheostomy Tube5.5
60PFPS60Bivona® Uncuffed Pediatric FlexTend™ Plus Extra Length Tracheostomy Tube6.0
60PFS25Bivona® Uncuffed Pediatric FlexTend™ Plus Standard Tracheostomy Tube2.5
60PFS30Bivona® Uncuffed Pediatric FlexTend™ Plus Standard Tracheostomy Tube3.0
60PFS35Bivona® Uncuffed Pediatric FlexTend™ Plus Standard Tracheostomy Tube3.5
60PFS40Bivona® Uncuffed Pediatric FlexTend™ Plus Standard Tracheostomy Tube4.0
60PFS45Bivona® Uncuffed Pediatric FlexTend™ Plus Standard Tracheostomy Tube4.5
60PFS50Bivona® Uncuffed Pediatric FlexTend™ Plus Standard Tracheostomy Tube5.0
60PFS55Bivona® Uncuffed Pediatric FlexTend™ Plus Standard Tracheostomy Tube5.5
60PFSS25Bivona® Uncuffed Pediatric FlexTend™ Plus Standard Tracheostomy Tube2.5
60PFSS30Bivona® Uncuffed Pediatric FlexTend™ Plus Standard Tracheostomy Tube3.0
60PFSS35Bivona® Uncuffed Pediatric FlexTend™ Plus Standard Tracheostomy Tube3.5
60PFSS40Bivona® Uncuffed Pediatric FlexTend™ Plus Standard Tracheostomy Tube4.0
60PFSS45Bivona® Uncuffed Pediatric FlexTend™ Plus Standard Tracheostomy Tube4.5
60PFSS50Bivona® Uncuffed Pediatric FlexTend™ Plus Standard Tracheostomy Tube5.0
60PFSS55Bivona® Uncuffed Pediatric FlexTend™ Plus Standard Tracheostomy Tube5.5
60SN025Bivona® Uncuffed Neonatal Tracheostomy Tube2.5
60SN030Bivona® Uncuffed Neonatal Tracheostomy Tube3.0
60SN035Bivona® Uncuffed Neonatal Tracheostomy Tube3.5
60SN040Bivona® Uncuffed Neonatal Tracheostomy Tube4.0
60SP025Bivona® Uncuffed Neonatal Tracheostomy Tube2.5
60SP030Bivona® Uncuffed Neonatal Tracheostomy Tube3.0
60SP035Bivona® Uncuffed Neonatal Tracheostomy Tube3.5
60SP040Bivona® Uncuffed Neonatal Tracheostomy Tube4.0
60SP045Bivona® Uncuffed Neonatal Tracheostomy Tube4.5
60SP050Bivona® Uncuffed Neonatal Tracheostomy Tube5.0
60SP055Bivona® Uncuffed Neonatal Tracheostomy Tube5.5
65N025Bivona® Aire-Cuf® Neonatal Tracheostomy Tube2.5
65N030Bivona® Aire-Cuf® Neonatal Tracheostomy Tube3.0
65N035Bivona® Aire-Cuf® Neonatal Tracheostomy Tube3.5
65N040Bivona® Aire-Cuf® Neonatal Tracheostomy Tube4.0
65N025Bivona® Aire-Cuf® Neonatal Tracheostomy Tube2.5
65P030Bivona® Aire-Cuf® Pediatric Tracheostomy Tube3.0
65P035Bivona® Aire-Cuf® Pediatric Tracheostomy Tube3.5
65P040Bivona® Aire-Cuf® Pediatric Tracheostomy Tube4.0
65P045Bivona® Aire-Cuf® Pediatric Tracheostomy Tube4.5
65P050Bivona® Aire-Cuf® Pediatric Tracheostomy Tube50
65P055Bivona® Aire-Cuf® Pediatric Tracheostomy Tube5.5
65SN025Bivona® Aire-Cuf® Pediatric Tracheostomy Tube2.5
65SN030Bivona® Aire-Cuf® Pediatric Tracheostomy Tube3.0
65SN035Bivona® Aire-Cuf® Pediatric Tracheostomy Tube3.5
65SN040Bivona® Aire-Cuf® Pediatric Tracheostomy Tube4.0
65SP025Bivona® Aire-Cuf® Pediatric Tracheostomy Tube2.5
65SP030Bivona® Aire-Cuf® Pediatric Tracheostomy Tube3.0
65SP035Bivona® Aire-Cuf® Pediatric Tracheostomy Tube3.5
65SP040Bivona® Aire-Cuf® Pediatric Tracheostomy Tube4.0
65SP045Bivona® Aire-Cuf® Pediatric Tracheostomy Tube4.5
65SP050Bivona® Aire-Cuf® Pediatric Tracheostomy Tube5.0
65SP055Bivona® Aire-Cuf® Pediatric Tracheostomy Tube5.5
67N025Bivona® TTS™ Cuffed Pediatric Tracheostomy Tube2.5
67N030Bivona® TTS™ Cuffed Pediatric Tracheostomy Tube3.0
67N035Bivona® TTS™ Cuffed Pediatric Tracheostomy Tube3.5
167N040Bivona® TTS™ Cuffed Pediatric Tracheostomy Tube4.0
67P025Bivona® TTS™ Cuffed Pediatric Tracheostomy Tube2.5
67P030Bivona® TTS™ Cuffed Pediatric Tracheostomy Tube3.0
67P035Bivona® TTS™ Cuffed Pediatric Tracheostomy Tube3.5
67P040Bivona® TTS™ Cuffed Pediatric Tracheostomy Tube4.0
67P045Bivona® TTS™ Cuffed Pediatric Tracheostomy Tube4.5
67P050Bivona® TTS™ Cuffed Pediatric Tracheostomy Tube5.0
67P055Bivona® TTS™ Cuffed Pediatric Tracheostomy Tube5.5
67SN025Bivona® TTS™ Cuffed Pediatric Tracheostomy Tube2.5
67SN030Bivona® TTS™ Cuffed Pediatric Tracheostomy Tube3.0
67SN035Bivona® TTS™ Cuffed Pediatric Tracheostomy Tube3.5
67SN040Bivona® TTS™ Cuffed Pediatric Tracheostomy Tube4.0
67SP025Bivona® TTS™ Cuffed Pediatric Tracheostomy Tube2.5
67SP030Bivona® TTS™ Cuffed Pediatric Tracheostomy Tube3.0
67SP035Bivona® TTS™ Cuffed Pediatric Tracheostomy Tube3.5
67SP040Bivona® TTS™ Cuffed Pediatric Tracheostomy Tube4.0
67SP045Bivona® TTS™ Cuffed Pediatric Tracheostomy Tube4.5
67SP050Bivona® TTS™ Cuffed Pediatric Tracheostomy Tube5.0
67SP055Bivona® TTS™ Cuffed Pediatric Tracheostomy Tube5.5
Smiths Medical is notifying its customers through the U.S. mail. Recipients of the Urgent Field Safety Notice who have distributed the Affected Tubes to other persons or facilities should promptly forward a copy of the Urgent Field Safety Notice accordingly.
For questions regarding this Recall, customers should contact:
Smiths Medical Customer Service (Monday – Friday 8am – 8pm CST)
800-258-5361, Option 1
bivona.tr3@smiths-medical.comCustomers should report any issues with the Bivona® Neonatal, Pediatric and FlexTend Tracheostomy Tubes to Smiths Medical’s Complaints Department at 1-866-216-8806.
Any adverse events that may be related to the use of this product should be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
Online at www.fda.gov/MedWatch/report.htm3 Regular Mail; use postage-paid, pre-addressed Form FDA 3500 available at: www.fda.gov/MedWatch/getforms.htm4 [*]Fax 1-800-FDA-0178.
About Smiths Medical
Smiths Medical www.smiths-medical.com is a leading supplier of specialized medical devices and equipment for global markets, focusing on the medication delivery, vital care and safety devices market segments. It is part of Smiths Group www.smiths.com, a global leader in applying advanced technologies for markets in threat and contraband detection, energy, medical devices, communications and engineered components. Smiths Group employs around 22,000 people in more than 50 countries
我院曾用过此品牌的气管插管，但不知是否是这些批号，以通知相关人员核查。谢谢提醒！goodnight! 不懂外语{:1_10:}，所以看了也等于没有看。哪位老师可以翻译一下品牌？谢谢！
FDA发布气管切开插管一级召回令
2012年2月25日，FDA发布一项有关气管切开插管的一级召回令，这是FDA最高级别的召回令，意味着有患者可能会因此受伤或死亡。FDA公布这些插管的生产商为英国Smiths医疗国际有限公司，注册商标为Bivona（点击查看涉事插管的产品批次）。有报告称在移除这些涉事插管附件时，需要额外加力，有时甚至无法拔出，这有可能会导致患者受伤或死亡。在某些情况下，用力拔出插管时，会导致松脱现象。此时患者往往需要紧急更换插管。
FDA表示使用者需要鉴别目前正在使用的插管，避免使用涉事插管并更换为未受影响的产品。通常情况下，这些产品常在卫生保健结构或家庭中使用。
scgyygy 发表于 2012-2-28 23:59 static/image/common/back.gif
不懂外语，所以看了也等于没有看。哪位老师可以翻译一下品牌？谢谢！
国外的商品都是英文名啊。这个翻译应该没什么用吧。 比较恐怖的事情。。。貌似国内也有用这个牌子啊！{:1_10:} 谢谢老师提醒，但我院好像没有使用英国的产品样？我倒是应该去查查哈！{:1_17:}
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