Portex A4051

• FDA 510(k) K965017 decided 14 Mar 1997 Active
• FDA GUDID UDI-DI 20351688080438 listed 9 Jan 2017 Listed

• • Ongoing Z-1101-2026 FDA Class II ·initiated 19 Dec 2025

  Affected lots of syringes may have a crack on the syringe collar, which may lead to delayed or repeated blood draw/fluid delivery. This issue may also lead to blood leakage during sampling of arterial blood or leakage during fluid delivery.

• • Terminated Z-0211-2007 FDA Unclassified (pre-2012) ·initiated 27 Oct 2006

  Misbranded: Tray label states 26G x 5/8 inch, needle is 25 G x 1 inch

• 4 recalls, same reason

  • Terminated Z-0244-06 FDA Unclassified (pre-2012) ·initiated 17 Nov 2005
  • Terminated Z-0245-06 FDA Unclassified (pre-2012) ·initiated 17 Nov 2005
  • Terminated Z-0242-06 FDA Unclassified (pre-2012) ·initiated 17 Nov 2005
  • Terminated Z-0243-06 FDA Unclassified (pre-2012) ·initiated 17 Nov 2005

  Tray may contain holes compromising the sterility of the device

• • Terminated Z-0166-04 FDA Unclassified (pre-2012) ·initiated 10 Oct 2003

  Spinal trays labeled as containing a Whitacre 25g x 3.5' needle actually contain a Quincke 25g x 3.5' needle.

1. 14 Mar 1997 Cleared FDA 510(k) K965017
2. 10 Oct 2003 Recall initiated FDA recalls Z-0166-04
3. 17 Nov 2005 Recall initiated FDA recalls Z-0244-06
4. 17 Nov 2005 Recall initiated FDA recalls Z-0245-06
5. 17 Nov 2005 Recall initiated FDA recalls Z-0242-06
6. 17 Nov 2005 Recall initiated FDA recalls Z-0243-06
7. 27 Oct 2006 Recall initiated FDA recalls Z-0211-2007
8. 9 Jan 2017 Listed FDA GUDID 20351688080438
9. 19 Dec 2025 Recall initiated FDA recalls Z-1101-2026

Trade name

Portex

Generic name

Epidural anaesthesia set, medicated

Model / reference

A4051

Primary DI / UDI-DI

20351688080438

510(k) Number

K965017 ↗

FDA product code

CAZ

GMDN term

Epidural anaesthesia set, medicated

Device class

Class II

Regulation number

868.5140

GUDID distribution status

In Commercial Distribution

Category: Epidural anaesthesia set, medicated

Other devices filed under FDA product code CAZ (Anesthesia conduction kit).

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• ARROW FlexBlock Continuous Peripheral Nerve Block Catheter Kit/Set by Teleflex LLC
• CONTINUOUS EPIDURAL ANESTHESIA TRAY by Portex, Ltd.
• BUSSE PLASTIC LOR SYRINGE by BUSSE HOSPITAL DISPOSABLES
• VARIOUS ANESTHETIC KITS OR TRAYS by SPECIALTY MEDICAL PRODUCTS CO.
• Arrow 0.2 Micron Flat Filter, GVS by Arrow International, Inc.
• B-D DURASAFE COMBINED SPINAL EPIDURAL (CSE) TRAY by Bd Becton Dickinson Vacutainer Systems Preanalytic
• MEDSURG EPIDURAL TRAY/19 GAGE OPEN END TUOHY 1012 by Medsurg Industries, Inc.
• PLEXOLONG SETS by Pajunk GmbH

• Bivona FT26JN30NGF219N

  Class II

  FDA 510(k) K923878 Active Cleared 29 Dec 1992 GUDID on market

• Bivona HT26JS70NSC222N

  Class II

  FDA 510(k) K923878 Active Cleared 29 Dec 1992 GUDID on market

• Bivona HT26JS80NSC205N

  Class II

  FDA 510(k) K923878 Active Cleared 29 Dec 1992 GUDID on market

• Bivona ST26JN55NSA204N

  Class II

  FDA 510(k) K923878 Active Cleared 29 Dec 1992 GUDID on market

See all devices from ICU Medical, Inc. →