Device Recall Shiley

  • Model / Serial
    United States distributed product includes: 8FEN lots 0910000342 to 1101001558 and 110300622X to 120600700X; 8LPC lots 0910000348 to 1101001823 and 110200327X to 120600351X.  Product Distributed outside of the United States: 8FENJ lots 1003002176, 1004000412, and 120100433X. 8FEN-S lot 0910001010; 8FENJ-S lots 0910002075 to 1103002299 and 110601803X to 120402125X; and 8LPC-S lots 0910001002 to 1103002052 and 111000400X to 120600014X.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Nationwide
  • Product Description
    Shiley Reusable Cannula Low Pressure Cuffed Tracheostomy Tubes, model numbers (Worldwide) 8LPC, 8FEN; (Outside U.S.) 8FENJ, 8FENJ-S, 8LPC-S, 8FEN-S. || Product Usage: The product is intended for use to bypass upper airway obstructions, provide long term ventilation, support and/or manage tracheal/bronchial secretions. The product is sold as sterile. The packaging may indicate either Covidien or Tyco as the manufacturer as the firm has transitioned from Tyco to Covidien over the past 4 years.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Nellcor Puritan Bennett Inc. (dba Covidien LP), 6135 Gunbarrel Ave, Boulder CO 80301-3214
  • Manufacturer Parent Company (2017)
  • Manufacturer comment
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA

5 devices with a similar name

Learn more about the data here

  • Model / Serial
    All products manufactured since 2/2012. Including All lot numbers beginning with 12, 13 and 14.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution. US nationwide, Canada, Australia, Belgium, Chile, Germany, Israel, Italy, Japan, Saudi Arabia, Singapore, South Africa, Turkey, and Uruguay.
  • Product Description
    Shiley Neonatal, Pediatric and Long Pediatric Tracheostomy Tube, Cuffless. Model Numbers: 2.5NEF,3.0NEF,3.5NEF,4.0NEF,4.5NEF,2.5PEF,3.0PEF,3.5PEF,4.0PEF,4.5PEF,5.0PEF,5.5PEF,5.0PELF,5.5PELF,6.0PELF,6.5PELF,2.5NCF,3.0NCF,3.5NCF,4.0NCF,4.5NCF,2.5PCF,3.0PCF,3.5PCF,4.0PCF,4.5PCF,5.0PCF,5.5PCF,5.0PLCF,5.5PLCF,6.0PLCF,6.5PLCF,3.0NEF-P,3.5NEF-P,4.0NEF-P,4.5NEF-P,3.0PEF-P,3.5PEF-P,4.0PEF-P,4.5PEF-P,5.0PEF-P,5.5PEF-P,
  • Manufacturer
  • Model / Serial
    All products manufactured since 2/2012.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution. US nationwide, Canada, Australia, Belgium, Chile, Germany, Israel, Italy, Japan, Saudi Arabia, Singapore, South Africa, Turkey, and Uruguay.
  • Product Description
    Shiley Neonatal, Pediatric and Long Pediatric Tracheostomy Tube with TaperGuard Cuff. || Intended for use in providing tracheal access for airway managements.
  • Manufacturer
  • Model / Serial
    All units of these models.
  • Product Classification
  • Distribution
    The tracheostomy tubes were distributed to 4,179 direct US and US Territory customers. The firm has also distributed products to Canada, the UK, Latin America and Japan. The firm's branches in those countries are handling the recall activities in those countries. The firm manufactured 95,923 units and distributed 71.021 throughout the US and US territories. 4,481 are on hold at the Nellcor distribution facility, and approximately 3000 units are currently in distribution.
  • Product Description
    Shiley TracheoSoft¿ XLT Extended Length Tracheostomy tube; || Model Numbers: || 72110-050, size 5, Proximal Extension, Uncuffed; || 72110-060, size 6, Proximal Extension, Uncuffed; || 72110-070, size 7, Proximal Extension, Uncuffed; || 72110-080, size 8, Proximal Extension, Uncuffed; || 72120-050, size 5, Promixal Extension, Cuffed; || 72120-060, size 6, Promixal Extension, Cuffed; || 72120-070, size 7, Promixal Extension, Cuffed; || 72120-080, size 8, Promixal Extension, Cuffed; || 73110-050, size 5, Distal Extension, Uncuffed; || 73110-060, size 6, Distal Extension, Uncuffed; || 72110-070, size 7, Distal Extension, Uncuffed; || 73110-080, size 8, Distal Extension, Uncuffed; || 73120-050, size 5, Distal Extension, Cuffed; || 73120-060, size 6, Distal Extension, Cuffed; || 73120-070, size 7, Distal Extension, Cuffed; || 73120-080, size 8, Distal Extension, Cuffed; || 77100-050, size 5 XLT Disposal Inner Cannula; || 77100-060, size 6 XLT Disposal Inner Cannula; || 77100-070, size 7 XLT Disposal Inner Cannula; || 77100-080, size 8 XLT Disposal Inner Cannula || Manufactured by Mallinckrodt Medical, County Westmeath Cornamaddy, Athlone, Ireland; || Customer Service: Mallinckrodt, Inc. St Louis, MO 63134
  • Manufacturer
  • Model / Serial
    All codes are affected.
  • Product Classification
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    The firm has indicated that product was released for distribution to 7 consignees in US and to 17 foreign countries via international distribution centers. The firm has indicated that a very limited number of the product was distributed in the US to selected facilities that were participating in customer preference testing, after the device had received 510(k) clearance and all remaining stock was collected and returned to the company. Tyco Healthcare/Nellcor shipped Tyco Healthcare affiliate offices outside of the US. Foreign distribution include: Australia, Austria, Belgium, Canada, Denmark, Finland, France, Germany, Holland, Italy, Norway, Poland, Singapore, Spain, Sweden, Switzerland and United Kingdom.
  • Product Description
    Shiley FlexTra brand Flexible Dual-Cannula Tracheostomy Tube, || Models: 358060, Size 6, FlexTra Cuffed; 358070, Size 7, FlexTra Cuffed; || 358080, Size 8, FlexTra Cuffed; 358090, Size 9, FlexTra Cuffed; 358100, Size 10, FlexTra Cuffed; 359060, Size 6, FlexTra Uncuffed; 359070, Size 7, FlexTra Uncuffed; 359080, Size 8, FlexTra Uncuffed; 359090, Size 9, FlexTra Uncuffed; 359100, Size 10, FlexTra Uncuffed, || Tyco Healthcare/Nellcor is currently responsible for Research and Development for this product. Tyco Healthcare/MMJ S.A. De C.V., Cuidad Juarez, Mexico manufactures the FlexTra Tracheostomy Tube. The product is sterilized at Sterigenics, located at Santa Teresa, New Mexico.
  • Manufacturer
  • Model / Serial
    Lot Numbers: 0806000266, 0806000858, 0806000859, 0806001328, 0807000555, 0807001444, 0807002502, 0808000387, 0808000431, 0808002285, 0810000288, 0810000289, 0810000864, 0810000865, 0810001201, 0811000228, 0811000522, 0811000523, 0811000546, 0811000547 and 0811001875.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution, including Puerto Rico.
  • Product Description
    Shiley PED3.0 Cuffless Pediatric Tracheostomy Tube, REF 3.0 PED, Sterile. Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Assembled in Mexico. The product is provided as one each shipped in an inner carton to end customers. || The intended use of the device is to bypass upper airway obstructions, provide long term ventilation, and support and/or manage tracheal/bronchial secretions.
  • Manufacturer