| Class 2 Device Recall Extremity Pack | |
Date Initiated by Firm | January 11, 2017 |
Date Posted | February 28, 2017 |
Recall Status1 |
Terminated 3 on May 03, 2017 |
Recall Number | Z-1295-2017 |
Recall Event ID |
76280 |
Product Classification |
Light, surgical, ceiling mounted - Product Code FSY
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Product | Extremity Pack, part number AMS3240
Extremity Pack, part number AMS4764
Extremity Pack, part number AMS4788(A
Extremity Pack, part number PSS1798(A
Extremity Pack, part number PSS1798(A
Extremity Pack, part number PSS1798(A
Extremity Pack, part number PSS1842(A
Extremity Pack, part number PSS1842(A
Extremity Pack, part number PSS1842(A
Extremity Pack, part number PSS1842(A
Extremity Pack, part number PSS2706
Extremity Pack, part number PSS2706
Extremity Pack, part number PSS2706
Extremity Pack, part numbre PSS2706
Extremity Pack, part number PSS2706
Extremity Pack, part number PSS2706
Extremity Pack, part number PSS2706
Extremity Pack, part number PSS2706
Extremity Pack, part number PSS2706
Extremity Pack, part number PSS2706
Extremity Pack, part number PSS2706(A
Extremity Pack, part number PSS2706(A
Extremity Pack, part number PSS2706(A
Extremity Pack, part number PSS2706(A |
Code Information |
Lot number and expiration date 100226, 9/11/2019 101400, 10/7/2019 84373, 5/28/2018 84678, 6/8/2018 84896, 5/26/2018 84959, 7/29/2018 85470, 2/23/2017 85505, 7/23/2018 85547, 8/23/2018 85695, 7/8/2018 85846, 8/5/2018 86258, 9/19/2018 86509, 9/28/2018 86663, 8/11/2019 86686, 9/9/2018 86908, 9/13/2018 87155, 9/16/2018 87730, 7/5/2017 87968, 9/6/2018 88008, 7/1/2017 88862, 2/7/2018 89394, 11/15/2017 89546, 7/21/2017 89832, 12/29/2018 95313, 9/16/2019 95453, 1/22/2019 95880, 6/12/2019 96000, 1/6/2019 96383, 5/25/2018 96384, 5/13/2018 96923, 5/1/2019 97709, 5/1/2019 99376, 6/7/2019 |
Recalling Firm/ Manufacturer |
Windstone Medical Packaging, Inc. 1602 4th Ave N Billings MT 59101-1521
|
For Additional Information Contact | Vicki Davis 321-527-7714 |
Manufacturer Reason for Recall | 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. |
FDA Determined Cause 2 | Nonconforming Material/Component |
Action | 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. |
Quantity in Commerce | 810 kits |
Distribution | 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. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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