Portex Lo-Profile Tracheostomy Tube Decannulation Cap recallZ-0229-05 · Smiths Medical ASD, Inc. · initiated Sep 9, 2004
Terminated All recalls posted in November 2004
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Smiths Medical ASD, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Sterility of the device is compromised due to packaging defects
FDA root cause category: Other
What the company is doing
Smiths Medical, ASD notified consignees by letter dated September 9, 2004 by FedEx. Customers and dealers are directed to fax back the attached Reply Letter to the Smiths Medical Regulatory Affairs Department at 603-358-1017, even if the customer/dealer no longer has affected products in inventory, Questions are directed to Customer Service at 1-800-258-5361, prompt 1. On 9/17/04, Smiths notified 48 consignees by Fed''X letter of 3 -additional lot codes for Product Code: 4252.
Recall details
- Recall number
- Z-0229-05
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Sep 9, 2004
- Posted by the FDA
- Nov 24, 2004
- Recalling firm
- Smiths Medical ASD, Inc.
- Product code
- BTO
- FDA submissions
- K922749, K934465
- Distribution
- Nationwide
Product description
Portex Lo-Profile Tracheostomy Tube Decannulation Cap Catalog Number: 582000
Code information (models, lots, serial numbers)
Lot numbers starting with: 1, K1, K2, K50
Other devices under the same FDA submission
9 devices cleared under K922749, K934465 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Portex 503060Icu Medical, Inc. · Tube, tracheal (w/wo connector)13 reports
- Portex 503070Icu Medical, Inc. · Tube, tracheal (w/wo connector)9 reports
- Portex 505070Icu Medical, Inc. · Tube, tracheal (w/wo connector)7 reports
- Portex 513060Icu Medical, Inc. · Tube, tracheal (w/wo connector)3 reports
- Portex 505080Icu Medical, Inc. · Tube, tracheal (w/wo connector)2 reports
- Portex 503080Icu Medical, Inc. · Tube, tracheal (w/wo connector)1 report
- Portex 513070Icu Medical, Inc. · Tube, tracheal (w/wo connector)1 report
- Portex 505090Icu Medical, Inc. · Tube, tracheal (w/wo connector)1 report
- Portex 513080Icu Medical, Inc. · Tube, tracheal (w/wo connector)1 report
Other products in the same recall event
The FDA groups related products into one recall event (event 29990).
- Z-0227-05 · TerminatedPortex Pro-Vent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes Catalog Number: 4589P-1
- Z-0228-05 · TerminatedPortex Tracheostomy Tube Decannulation Cap for use only with Fenestrated Tracheostomy Tubes Catalog Number: 519000
- Z-0244-05 · TerminatedPortex Custom Pro-Vent Arterial Blood Sampling Kit Catalog Number: G1481
- Z-0246-05 · TerminatedPortex Custom Pro-Vent Arterial Blood Sampling Kit Catalog Number: G1488
- Z-0247-05 · TerminatedPortex Custom Pro-Vent Arterial Blood Sampling Kit Catalog Number: G1515
- Z-0248-05 · TerminatedPortex Custom Pro-Vent Arterial Blood Sampling Kit Catalog Number: G1540
- Z-0249-05 · TerminatedPortex Custom Pro-Vent Arterial Blood Sampling Kit Catalog Number: G1554
- Z-0250-05 · TerminatedPortex Custom Pro-Vent Arterial Blood Sampling Kit Catalog Number: G1560
- Z-0251-05 · TerminatedPortex Custom Pro-Vent Arterial Blood Sampling Kit Catalog Number: G1562
- Z-0252-05 · TerminatedPortex Custom Pro-Vent Arterial Blood Sampling Kit Catalog Number: G1576
- Z-0253-05 · TerminatedPortex Custom Pro-Vent Arterial Blood Sampling Kit Catalog Number: G1615
- Z-0254-05 · TerminatedPortex Custom Pro-Vent Arterial Blood Sampling Kit Catalog Number: G1696
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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