| Class 2 Device Recall Pacemaker Kit |  |
Date Initiated by Firm | January 11, 2017 |
Date Posted | February 28, 2017 |
Recall Status1 |
Terminated 3 on May 03, 2017 |
Recall Number | Z-1356-2017 |
Recall Event ID |
76280 |
Product Classification |
Light, surgical, ceiling mounted - Product Code FSY
|
Product | Pacemaker Kit, part number AMS4281
Pacemaker Kit, part number AMS4281(A
Pacemaker Kit, part number AMS4281(C
Pacemaker Kit, part number AMS4281(D |
Code Information |
Lot number and expiration date 80492, 5/3/2018 82502, 6/8/2018 85302, 7/12/2018 88153, 11/13/2018 89116, 12/10/2018 89318, 11/22/2018 95070, 1/29/2019 95088, 11/14/2018 95580, 1/4/2019 95581, 1/4/2019 95582, 1/11/2019 95583, 1/24/2019 97115, 6/12/2019 |
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 | 561 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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