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U.S. Department of Health and Human Services

Class 2 Device Recall 3M Scotchcast

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  Class 2 Device Recall 3M Scotchcast see related information
Date Initiated by Firm August 05, 2013
Date Posting Updated September 18, 2013
Recall Status1 Terminated 3 on June 16, 2014
Recall Number Z-2242-2013
Recall Event ID 66052
Product Classification Bandage, cast - Product Code ITG
Product 3M Scotchcast, Wet or Dry Cast Padding, Catalog Numbers WDP2, WDP3, WDP4, and WDP6.


Intended for use in constructing casts for either wet or dry immobilization.
Code Information Catalog # - Lot #, WDP2 - 792920, 793090, 793640 & 796078., WDP3 - 792921, 793098, 793638, 796077 & 798487., WDP4 - 792922, 793116, 793637, 796079 & 798488., WDP6 792923, 793636, 798489, 799235 & 799236.
Recalling Firm/
Manufacturer
3M Company - Health Care Business
3M Center 2510 Conway Ave , B# 275-5-W-6
Saint Paul MN 55144
For Additional Information Contact
651-733-1110
Manufacturer Reason
for Recall
3M is conducting a voluntary product recall of selected lots of 3M" Scotchcast" Wet or Dry Cast Padding. Upon investigation of a health care provider feedback, and confirmed with internal testing, it was found that the cast padding material does not consistently repel water. Lack of repellency may result in prolonged cast dry times after exposure to wet conditions. There have been no repo
FDA Determined
Cause 2
Nonconforming Material/Component
Action 3M sent a Voluntary Product Recall Notification letter dated July 31, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were asked to examine their inventory and set aside any affected lots subject to the recall notice. Customers were asked to inform all departments of any affected lots and provide them with a copy of the Notification letter that instructs them to contact their 3M distributor for alternative options. All affected products were to be returned to the 3M distributor they were purchased from. Customers with questions were instructed to contact the 3M Customer Helpline at 1-800-228-3957. For questions regarding this recall call 651-733-1110.
Quantity in Commerce 1207 cases (4 puches per case, 20 rolls per pouch)
Distribution Worldwide Distribution - USA including AL, AZ, AR, CA, CO,CT, FL, GA, HI, IL, IN,KS,KY, LA, MD, MA, MI, MN, MO, NE, NV, NJ, NY, NC, OH, OR,PA, TN, TX, UT,VA, WA, and WI. Internationally to GERMANY, CANADA, BELGIUM, NETHERLANDS, HONG KONG, NEW ZEALAND, AUSTRALIA, INDIA, KOREA, SINGAPORE AND UNITED ARAB EMIRATES, JAPAN, JAMAICA..
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.
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