medical Class II Updated 2018-09-19

SPS Sterilization, Inc recalls Boston Scientific Wallstent RP Endoprosthesis Tracheobronchi

Recalled Product

Boston Scientific Wallstent RP Endoprosthesis Tracheobronchial Self-Expanding Stent, 10MM X 94MM | 135CM, resterilized.

Hazard / Issue

The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the extended shelf life.

Issued by

FDA

Affected States: AZ, CA, FL, OH, PA, TX, VA, WV
Lot/Code Info: Code Number 71139-R; Lot Numbers 17752073, 17752073, 17422520; Serial Numbers 21408032017-03, 21408032017-04, 21408032017-05
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