Portex A4197Recalls & reported problems
Icu Medical, Inc. · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20351688082425), received between Jul 3, 2025 and Jul 3, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (1 report).
7 other recalls cover devices cleared under the same FDA submission (K965017); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 3, 2025Break
AFTER OPENING THE TRAY WE SAW ONE OF THE TWO LIDOCAINE AMPULES WERE BROKEN THIS IS THE THIRD TRAY IN A ROW.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22394206 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K965017. One submission often covers many models, so check the product and lot details in each record.
- Z-1101-2026 · Dec 19, 2025 · Open, ClassifiedPortex Spinal Tray, Item No. A3729-24 A3595
- Z-0211-2007 · Oct 27, 2006 · TerminatedPortex Continuous Epidural tray Ref 4948-17
- Z-0245-06 · Nov 17, 2005 · Terminated4950-16 Portex Epidural Mini-pack
- Z-0244-06 · Nov 17, 2005 · Terminated4904 Glass L.O.R. Syringe
- Z-0242-06 · Nov 17, 2005 · Terminated4902 Glass L.O.R. Syringe
- Z-0243-06 · Nov 17, 2005 · Terminated4903 Glass L.O.R. Syringe
- Z-0166-04 · Oct 10, 2003 · TerminatedPortex Spinal Tray with 25G Whitacre Needle. Kit contains Bupivacaine in Dextrose, Epinephrine,Lidocaine, Lidocaine in Dextrose and Tetracaine Catalog Number: 15545-20
Other Anesthesia conduction kit devices
- BD Luer-Lok, BD Glaspak 405671Becton, Dickinson And Company · Anesthesia conduction kit1 recall68 reports
- ARROW IPN922678Teleflex Incorporated · Anesthesia conduction kit2 recalls0 reports
- BD Luer-Lok, BD Glaspak 405672Becton, Dickinson And Company · Anesthesia conduction kit1 recall27 reports
- BD Luer-Lok, BD Glaspak 405673Becton, Dickinson And Company · Anesthesia conduction kit1 recall10 reports
- BD Luer-Lok, BD Glaspak 405637Becton, Dickinson And Company · Anesthesia conduction kit1 recall7 reports
- BD Luer-Lok, BD Glaspak 405707Becton, Dickinson And Company · Anesthesia conduction kit1 recall4 reports
- BD Luer-Lok, BD Glaspak 405609Becton, Dickinson And Company · Anesthesia conduction kit1 recall3 reports
- BD Luer-Lok, BD Glaspak 405735Becton, Dickinson And Company · Anesthesia conduction kit1 recall3 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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