Portex Endotracheal Tube, Item Codes 100/105/025 100/105/030 100/105/035 100/111/020 100/111/025 100/111/030 100/111/035 100/111/035 100/126/025 100/126/030 100/126/035 100/127/025 100/127/030 100/127/035 100/141/025 100/141/030 100/141/035
FDA Recall Z-1289-2025 · Posted 2025-03-12
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Recalling FirmSmiths Medical ASD, Inc.
Recall StatusOpen, Classified
Product CodeBTR
Date Initiated2025-02-13
Reason for Recall
Affected devices have a smaller diameter than expected and may potentially result in inadequate ventilation to the patient. Patient may experience hypoxia, underdose, or cardiopulmonary collapse.
Firm Action
On February 13, 2025, the firm began to notify affected consignees via Urgent Medical Device Correction letters. Customers were informed that affected sizes of endotracheal tube products may have a smaller diameter than expected.
Customers were instructed to check all inventory locations for affected products and discontinue use. Affected product should be destroyed following your institution's process for destruction. Product should be quarantined until disposal.
All potential users of the device should be informed. If you have distributed affected product, please immediately forward the recall notice to your customers.
Root Cause
Process change control
Distribution Pattern
Worldwide - US Nationwide distribution.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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