Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-2242-2013Class II

3M Scotchcast, Wet or Dry Cast Padding, Catalog Numbers WDP2, WDP3, WDP4, and WDP6. Intended for use in...

3M Company / initiated 2013-08-05 / Terminated / root cause: manufacturing process

3M Company - Health Care Business began a recall of 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 on . FDA classified it as Class II and gives the reason as "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...". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-2242-2013
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
3M Company
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.
Product code
ITG Bandage, Cast
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
Root cause tag
manufacturing process
FDA root cause
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..
Product codes and lots
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

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-2242-2013
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-2242-2013Class IITerminatedVoluntary: Firm initiated