Recall Z-1276-2017— Windstone Medical Packaging, Inc.

Class II FDA medical device recall by Windstone Medical Packaging, Inc., initiated 2017-01-11, terminated 2017-05-03. FDA's recall record names no specific 510(k) clearance for this event. Product: Breast Augmentation Pack, part number AMS1786(A Breast Augmentation Pack, part number AMS2790(A Breast Augmentation Pack, part number AMS3324(B Breast Augmentation Pack, part number AMS4382 Breast Augmentation Pack, part number AMS4382(A Breast Augmentation Pack, part number AMS4382(B Breast Augmentation Pack, part number AMS4392 Breast Augmentation Pack, part number PSS3430. Reason: The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility..

Recalling firm

Windstone Medical Packaging, Inc.

Classification

Class II

Status

Terminated

Initiated

2017-01-11

Terminated

2017-05-03

Firm location

Billings, MT, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.