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Turbo Elite 0.9mm Turbo Elite (TE) RX, Model #410-154, tip diameter 0.9mm/.038 in, 4 Fr, sterile EO. Manufactured by Spectranetics, 96 Talamine Court, Colorado Springs, CO 80907. The pouch label of the 1.4mm TE Over the Wire (OTW) catheter, Ref # 414-151, L/N# 080417D was incorrectly labeled for size as 0.9mm TE RX, Ref# 410-154, L/N#080417D. The box labels are correct and match the devices in the pouch. The Spectranetics TURBO-BoosterTM guiding catheter is designed for directing and supporting Spectranetics laser catheters for use in the treatment of infrainguinal stenoses and occlusions.
FDA Recall
Terminated
·Spectranetics Corporation·Product code MJQ·July 4, 2008
MJM INTERNATIONAL CORPORATION
FDA registration
MJM INTERNATIONAL CORPORATION·10 products·🇺🇸 United States
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FDA UDI
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FDA UDI
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FDA UDI
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MAQ-OPS S. de R.L.
FDA registration
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MAQ-OPS, S. DE R.L.
FDA registration
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JIANGSU MJD MEDICAL TECHNOLOGY CO.,LTD.
FDA registration
JIANGSU MJD MEDICAL TECHNOLOGY CO.,LTD.·4 products·🇨🇳 China
Aria Expressions
FDA UDI
Ortho Organizers, Inc.·00190707110772·Aria Expressions Champagne .022 Kit U/L 5x5 MC HKS
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FDA UDI
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MJM WOODTONE LINE
FDA UDI
M J M International Corporation·00849229009773·
MJM INTERNATIONAL CORP
FDA UDI
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MJM INTERNATIONAL CORP
FDA UDI
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MJM WOODTONE LINE
FDA UDI
M J M International Corporation·00849229008271·
MJM WOODTONE LINE
FDA UDI
M J M International Corporation·00849229008288·
MJM WOODTONE LINE
FDA UDI
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MJS POSTERIOR STABILIZED KNEE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
SODIUM/POTASSIUM 140/5 MEQ/L)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
SODIUM/POTASSIUM (100/100 MEQ/E)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
MJM
FDA Adverse Event
Death
·MJM·Product code ITJ·April 11, 2003