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U.S. Department of Health and Human Services

Class 2 Device Recall Arizant Bair Hugger Temperature Management Blanket

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  Class 2 Device Recall Arizant Bair Hugger Temperature Management Blanket see related information
Date Initiated by Firm March 11, 2005
Date Posted June 01, 2005
Recall Status1 Terminated 3 on January 10, 2007
Recall Number Z-0855-05
Recall Event ID 31379
510(K)Number K913734  K001149  
Product Classification System, Thermal Regulating - Product Code DWJ
Product Bair Hugger Temperature Management Blanket, Model 555 Pediatric Full Access Blanket. Use only with a Bair Hugger temperature managemen unit. Not Sterile. Do not use if primary packaging has been previously opened or is damaged. Arizant Healthcare Inc., 10393 West 70th Street, Eden Prairie, MN 55344 USA.
Code Information lot numbers ranging from 9631 up to and including 9657
Recalling Firm/
Arizant Inc
10393 W 70th St
Eden Prairie MN 55344
For Additional Information Contact Jami Collins
Manufacturer Reason
for Recall
Air channel seals on a limited number of Bair Hugger Model 555 Pediatric underbody blankets could separate when inflated with air from Bair Hugger warming unit. This separation would create a bulging area in the blanket's air channels, which could have a potential to shift the patient's position on the blanket.
FDA Determined
Cause 2
Action Recall notification was mailed to customers beginning 03/11/05. Customers were informed of the issue and asked to check their inventory for the affected lots. Affected lots found are to be quarantined and customers are to contact Arizant for instruction on returning affected product and receiving replacement product. Distributors are instructed to examine their inventory for affected lots, discontinue distribution and quarantine the lots. Distributors are asked to contact Arizant for returning affected product. If affected product was distributed, Distributors are to contact Arizant with names, addresses and telephone numbers of their accounts so Arizant can immediately inform those accounts of the recall.
Quantity in Commerce 88,320 blankets
Distribution nationwide
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.
510(K) Database 510(K)s with Product Code = DWJ and Original Applicant = AUGUSTINE MEDICAL, INC.