|
Class 2 Device Recall Laparoscopic Pack |
|
Date Initiated by Firm |
January 11, 2017 |
Date Posted |
February 28, 2017 |
Recall Status1 |
Terminated 3 on May 03, 2017 |
Recall Number |
Z-1330-2017 |
Recall Event ID |
76280 |
Product Classification |
Light, surgical, ceiling mounted - Product Code FSY
|
Product |
Laparoscopic Pack, part number AMS2499 Laparoscopic Pack, part number AMS2499(A Laparoscopic Pack, part number AMS2499(B
|
Code Information |
Lot number and expiration date 84903, 7/25/2018 85836, 8/22/2018 86720, 9/30/2018 86873, 8/16/2018 87104, 8/30/2018 88049, 10/29/2018 88170, 10/5/2018 88378, 11/15/2018 88379, 12/2/2018 89576, 11/15/2018 89577, 12/2/2018 89721, 12/17/2018 94931, 1/29/2019 94932, 1/5/2019 95274, 1/27/2019 95596, 1/13/2019 95983, 6/10/2019 96593, 5/1/2019 97448, 5/28/2019 97653, 6/17/2019 97654, 6/24/2019 97655, 6/21/2019 |
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 |
1056 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
|
|
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.
|
|
|
|