Portex Spinal Tray with 25G Whitacre Needle recallZ-0166-04 · Portex Inc · initiated Oct 10, 2003
Terminated All recalls posted in November 2003
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 Portex 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
Spinal trays labeled as containing a Whitacre 25g x 3.5' needle actually contain a Quincke 25g x 3.5' needle.
FDA root cause category: Other
What the company is doing
Portex notified consignees on 10/10/03 by letter issued by Federal Express. Distributors were asked to supply customer list to Portex or to notify their accounts with copy of the recall letter provided.
Recall details
- Recall number
- Z-0166-04
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Oct 10, 2003
- Posted by the FDA
- Nov 27, 2003
- Recalling firm
- Portex Inc
- Quantity
- 2600 units
- Product code
- CAZ
- FDA submissions
- K965017
Product description
Portex Spinal Tray with 25G Whitacre Needle. Kit contains Bupivacaine in Dextrose, Epinephrine,Lidocaine, Lidocaine in Dextrose and Tetracaine Catalog Number: 15545-20
Code information (models, lots, serial numbers)
Lot number: K203631 Exp. Date: 2004-08
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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