Bair Hugger Temperature Management Blanket, Model 555 Pediatric Full Access Blanket. Use only with a Bair Hugger tempera

FDA device recall Z-0855-05 · posted 2005-06-01 · Terminated

Recall details

Recalling firm

Arizant Inc

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.

Action taken

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.

Root cause

Other

Status

Terminated

Product code

DWJ

Quantity affected

88,320 blankets

Distribution

nationwide

Date initiated

2005-03-11

Date posted

2005-06-01

Date terminated

2007-01-10

Location

Eden Prairie, MN

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