Recall Z-0067-2017
Brathwaites Oliver Medical · initiated August 19, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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.
Codes / lots: Model OL-E12102, lot# 101615.
Reason for recall
The Introes Pocket Bougie an endotracheal tube introducer size 14 Fr (4.7mm) x 60 cm may break during intubation.
FDA-determined cause: Nonconforming Material/Component
Action taken
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 regulatory@bomimed.com to confirm this notification was received.
Details
- Recall number
- Z-0067-2017
- Initiated
- August 19, 2016
- Posted by FDA
- October 11, 2016
- Terminated
- July 19, 2019
- Product code
- BSR – Stylet, Tracheal Tube
- Quantity
- 760 units
- Distribution
- 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.
- Recalling firm
- Brathwaites Oliver Medical, Winnipeg Canada, Manitoba