Portex Continuous Epidural tray recallZ-0211-2007 · Smiths Medical ASD, Inc. · initiated Oct 27, 2006
Terminated All recalls posted in November 2006
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
Misbranded: Tray label states 26G x 5/8 inch, needle is 25 G x 1 inch
FDA root cause category: Other
What the company is doing
Smith Medical notified Dealers and direct customers contacted via letter delivered by Federal Express on October 27, 2006. Customers of dealers will be notified upon receipt of the dealer customer list.
Recall details
- Recall number
- Z-0211-2007
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Oct 27, 2006
- Posted by the FDA
- Nov 22, 2006
- Recalling firm
- Smiths Medical ASD, Inc.
- Quantity
- 540 units
- Product code
- CAZ
- FDA submissions
- K965017
- Distribution
- Nationwide and Panama
Product description
Portex Continuous Epidural tray Ref 4948-17
Code information (models, lots, serial numbers)
Lot Number: 1063342
Other devices under the same FDA submission
87 devices cleared under K965017 — 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 A3595Icu Medical, Inc. · Anesthesia conduction kit1 recall0 reports
- Portex A3729-24Icu Medical, Inc. · Anesthesia conduction kit1 recall0 reports
- Portex NLD-15597-20Icu Medical, Inc. · Anesthesia conduction kit32 reports
- Portex 49661C-25Icu Medical, Inc. · Anesthesia conduction kit21 reports
- Portex NEPI-NLD-15545C-21Icu Medical, Inc. · Anesthesia conduction kit20 reports
- Portex 24-1300-22Icu Medical, Inc. · Anesthesia conduction kit15 reports
- Portex NEPI-NLD-15597C-20Icu Medical, Inc. · Anesthesia conduction kit11 reports
- Portex 24-1301-22Icu Medical, Inc. · Anesthesia conduction kit10 reports
- Portex NLD-15545C-21Icu Medical, Inc. · Anesthesia conduction kit10 reports
- Portex 49662-25Icu Medical, Inc. · Anesthesia conduction kit9 reports
- Portex NEPI-NLD-15597-20Icu Medical, Inc. · Anesthesia conduction kit8 reports
- Portex 24-1302-22Icu Medical, Inc. · Anesthesia conduction kit7 reports
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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