2 Liter Latex-Free Breathing Bag; Reservoir Bag; Vendor Part Number: 720058B, Medline Item Number: 40054; Available in v

FDA device recall Z-1164-2008 · posted 2008-06-25 · Terminated

Recall details

Recalling firm

Medline Industries Inc

Reason for recall

Separation from Bushing: The breathing bag may separate from the bushing during use.

Action taken

Consignees were notified by a Sub-Recall Notice letter sent on 12/5/07. The letter instructed users to check their inventory for any affected product and to return a response card indicating the quantity of affected product. The users were instructed to return the affected products to the recalling firm so that they can be reworked. Users who did not wish to return the affected products could request a replacement product and were instructed to destroy the affected products. The letter also informed users that affected products in the manufacturer's inventory were being replaced and these replaced products would contain the label "INSPECTED." For additional information, contact 1-866-359-1704.

Root cause

Device Design

Status

Terminated

Product code

BTC

Quantity affected

57,000 bags

Distribution

Nationwide Distribution.

Date initiated

2007-12-07

Date posted

2008-06-25

Date terminated

2008-10-16

Location

Mundelein, IL