—#152878

Product

Lap Gallbladder Pack, part number AMS3707

FDA product code: FSY — Light, Surgical, Ceiling Mounted
Device class: Class 2
Medical specialty: General, Plastic Surgery
Affected lot / code info: Lot number and expiration date 100414, 10/20/2019 84309, 5/14/2018 84891, 6/9/2018 85661, 7/14/2018 86668, 9/5/2018 87290, 8/9/2019 88195, 11/15/2018 94578, 12/14/2018 95117, 3/6/2019 97136, 5/29/2019 98513, 6/2/2019 99066, 6/20/2019

Why it was recalled

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.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

AMS notified their consignees by Email, Fax, and Phone on 11/11/2017. AMS sent the notification letter, dated January 11, 2017, and provided yellow stickers "Recall Notice" to customers. They are advised to over-label the affected AMS kits at their facilities. Customers were instructed to place sticker in such a way that it would be immediately noticed but should not cover up or conceal any pertinent information such as Pack Number, Pack Name, Lot Number or Expiration Date on a kit. Customers with questions can call Vicki Davis at 321-527-7714 or send email to vdavis@alignedmedicalsolutions.com.

Recalling firm

Firm: Windstone Medical Packaging, Inc.
Address: 1602 4th Ave N, Billings, Montana 59101-1521

Distribution

Distribution pattern: Distributed in AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, and WA.

Timeline

Recall initiated: 2017-01-11
Posted by FDA: 2017-02-28
Terminated: 2017-05-03
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #152878. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.