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U.S. Department of Health and Human Services

Enforcement Report - Week of September 25, 2013

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Product Detail

Product Description 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.
Recall Number Z-2242-2013
Classification Class II
Code Info 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
Product Distributed Qty 1207 cases (4 puches per case, 20 rolls per pouch)
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 reports of patient injury associated with this material to date.

Event Detail

Event Id 66052
Product Type Devices
Status Ongoing
Recalling Firm 3M Company - Health Care Business
City Saint Paul
State MN
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-08-05
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern 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..
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