FDA Enforcement Class II Terminated

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: Z-2242-2013 · Reported September 25, 2013

Enforcement

Recall Number
Z-2242-2013
Event ID
66052
Classification
Class II
Status
Terminated
Product Type
Devices
Firm
3M Company - Health Care Business
Voluntary / Mandated
Voluntary: Firm initiated
Initial Notification
Letter
Report Date
September 25, 2013
Initiation Date
August 5, 2013
Classification Date
September 18, 2013
Termination Date
June 16, 2014
Address
3M Center 2510 Conway Ave , B# 275-5-W-6, N/A, Saint Paul, MN, 55144, United States

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.

Reason

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

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

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..

Quantity

1207 cases (4 puches per case, 20 rolls per pouch)