Class III

Model: Part Numbers: 1012587, 1012588, 1012589, 1012590, 1012591, 1012592, 1012593, 1012594, 1012595, Affected: All lot numbers

Model: , Affected:

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md

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Orthopedic Devices

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medical_device

medical_device

medical_device

Orthopedic Devices

medical_device

medical_device

medical_device

Lot Number: W3101005

Cardiovascular Devices

2

No

NY

ViaPeel PTFE Peelable Introducer 5FR, Part Number 10890-006

Model D140010, Lots: W3332609, W3338632, W3338635, W3338707, W3348350, W3348351, W3352503, W3359665, W3363850, W3363851, W3370052, W3374699, W3374700, W3379647, W3379650, W3384700, W3384701, W3390549, W3390551, W3397877, W3397879, W3397950, W3407814, W3407815, W3436351, W3436355, W3436356, W3436358, W3441735, W3441737, W3446767, W3446769, W3449392, W3451862, W3451863, W3455438,  W3455439, W3455440, W3459354, W3462467, W3462470, W3470335,  W3470336, W3483637, W3493240, W3497507, W3501348, W3501349,  W3581648, X3489776, X3497121, X3497510, X3501344, X3501345, X3503248,  X3507599, X3514814, X3518116, X3565743, X3581652, X3586059, X3592497.   Model D140011, Lots:

Cardiovascular Devices

2

No

CA

Biosense Webster MobiCath Bi-Directional Guiding Sheath, Model D140010 (small curve) and D140011 (large curve). || The MobiCath Bi-Directional Guiding Sheath is a flexible tipped percutaneous catheter introducer (or guiding sheath) designed for gaining access to the coronary systems. The device features adjustable tip geometry through use of a rotating handle to deflect the catheter. This catheter is assembled with a hemostasis valve and a sideport infusion line. || The kit includes a flexible catheter dilator to facilitate bi-directional guiding sheath passage.

All Small Angled Driver 45° are affected (see attached)

Pneumatic surgical reamer handpiece