4950-16 Portex Epidural Mini-pack recallZ-0245-06 · Smiths Medical ASD, Inc. · initiated Nov 17, 2005
Terminated All recalls posted in November 2005
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
Tray may contain holes compromising the sterility of the device
FDA root cause category: Other
What the company is doing
Smiths Medical ASD notffied accounts by letter via UPS or Fedex on November 17, 2005. Customers and dealers are directed to fax back the attached Reply Letter to Smiths Medical, Keene even if the customer/dealer no longer has affected products in inventory
Recall details
- Recall number
- Z-0245-06
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Nov 17, 2005
- Posted by the FDA
- Nov 30, 2005
- Recalling firm
- Smiths Medical ASD, Inc.
- Product code
- CAZ
- FDA submissions
- K965017
- Distribution
- Nationwide
Product description
4950-16 Portex Epidural Mini-pack
Code information (models, lots, serial numbers)
Lot Numbers: 101219, 103102, 105025, 106337, 109045, 110699, 111198, K110057, K110924, K124484, K128817, K132629, K141382, K144904, K147200, K148053, K157883, K160686, K163440, K189808, K211510, K221874, K511628 4950-17
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
Other products in the same recall event
The FDA groups related products into one recall event (event 34046).
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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