The Introes Pocket Bougie is an endotracheal tube introducer. The device is an endotracheal tube introducer and it is used as a guide during intubation. Anesthesiology.
FDA Recall Z-0067-2017 · Posted 2016-10-11
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Recalling FirmBrathwaites Oliver Medical
Recall StatusTerminated
Product CodeBSR
Date Initiated2016-08-19
Date Terminated2019-07-19
Product Quantity760 units
Reason for Recall
The Introes Pocket Bougie an endotracheal tube introducer size 14 Fr (4.7mm) x 60 cm may break during intubation.
Firm Action
On August 19, 2016 the firm sent a MEDICAL DEVICE RECALL NOTICE & CORRECTIVE ACTION letter to affected customers. The letter described the reason for the recall and necessary actions to be taken by the consignees. These included:
BOMImed is requesting bougies with lot# 101615 to be returned for evaluation due a potential manufacturing concern.
Complete the included Medical Device Recall Customer Letter and follow the instructions to obtain a Return Material Authorization number and
applicable shipping instructions to return the affected products.
BOMImed Regulatory department also requires the below Customer
Confirmation section to be completed and return to
[email protected] to confirm this notification was received.
Root Cause
Nonconforming Material/Component
Distribution Pattern
U.S. Consignee located in the following states: IL, WI, WE, OR, NY, UT, IN, NE, PA, MO, OH, AZ, MA, CT and NC.*** Foreign Consignee: Canada.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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