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FDA Medical Device Recalls (openFDA)

Portex Ltd.: Portex Uncuffed Oral Tracheal Tubes, Siliconized 6mm x 19cm Reference Number: 100/126/060

Recall number
Z-0995-03
Recalling firm
Portex Ltd.
Product
Portex Uncuffed Oral Tracheal Tubes, Siliconized 6mm x 19cm Reference Number: 100/126/060
Status
Terminated
Initiated
2003-05-16
Posted
2003-07-19
Terminated
2006-05-02
Reason
Tracheal tubes may be non-sterile
Root cause
Other
Action
Portex Inc. Keene,NH initiated the recall by telephone to direct accounts on 5/16/03. A follow-up Recall Notification letter was issued by Federal Express on May 17, 2003. Dealers were asked to provide a consignee list or contact their accounts directly. Unused product is requested to be returned from the distributors and medical facilities.
Quantity
10 units
Distribution
Nationwide
Lot, serial or model codes
Lot Number: 161669
510(k) numbers
not on file
PMA numbers
not on file
Product code
not on file
Firm FEI
3002807908
Firm city
Hythe Kent
Firm state
not on file
Firm country
United Kingdom

Where this comes from

Register
FDA Medical Device Recalls (openFDA)
Publisher
U.S. Food and Drug Administration (openFDA)
File
device-recall-0001-of-0001.json.zip
sha256
b87518bfe2e8
Size
288210821 bytes
Published
2026-09-28
Read
2026-09-29T08:25:23.626Z
Source file
Source file retained · verify
Refresh due
2026-10-06

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Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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