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Portex A4205-20

by ICU Medical, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

1 ongoing

This device is named in the recall

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number20351688082555 UDI-DI Date13 Jan 2017ListedStatusListed GUDID: in commercial distribution

Recalls

7 recalls · 1 ongoing · FDA

    • 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.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Portex
Generic Name
Epidural anaesthesia set, medicated
Model / Reference
A4205-20
Primary DI / UDI-DI
20351688082555
510(k) Number
FDA Product Code
CAZ
GMDN Term
Epidural anaesthesia set, medicated
Device Class
Class II
Regulation Number
868.5140
GUDID distribution status
In Commercial Distribution

Related devices

Category: Epidural anaesthesia set, medicated

Cleared under the same submission (K965017)

Show all (12)

Other devices from ICU Medical, Inc.

See all devices from ICU Medical, Inc. →

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Convenience Kit
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (7)

  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No