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Class 2 Device Recall Dr. Wischmeier Pack |
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Date Initiated by Firm |
March 16, 2017 |
Date Posted |
April 11, 2017 |
Recall Status1 |
Terminated 3 on June 06, 2017 |
Recall Number |
Z-1788-2017 |
Recall Event ID |
76774 |
Product Classification |
Light, surgical, ceiling mounted - Product Code FSY
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Product |
Dr. Wischmeier Pack, part numbers: AMS3509 and AMS3509(A Product packaged in a convenient manner for use in a general clinical procedure
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Code Information |
Lot numbers: 75870 78661 79154 81580 81800 83500 83594 83680 84118 84262 86073 86485 86887 87119 89180 95109 95422 95809 96760 97589 98512 99060 100410 101234 |
Recalling Firm/ Manufacturer |
Windstone Medical Packaging, Inc. 1602 4th Ave N Billings MT 59101-1521
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For Additional Information Contact |
Vicki Davis 321-527-7714
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Manufacturer Reason for Recall |
AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential for the sterile packaging of the eye pad to be compromised.
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FDA Determined Cause 2 |
Nonconforming Material/Component |
Action |
AMS sent an Urgent Medical Device Recall letter dated March 16, 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 should check inventory and complete the Recall Reply Form. Fax the completed form to Aligned Medical Solutions at 407-804-8460 or email the completed form to vdavis@alignedmedicalsolutions.com.
Customers can call Aligned Medical Solutions at 321-527-7714. |
Quantity in Commerce |
1,170 kits |
Distribution |
Nationwide Distribution including CA, CO, FL, GA, IA, KY, MA, MN, MO, ND, NJ, NV, OH, SD, TX, UT, WI, and WY. |
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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