ARROW IPN046378 (REF EC-05400-E)Recalls & reported problems
Teleflex Incorporated · Epidural Catheterization Set · 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 10801902128406), received between Apr 25, 2023 and Apr 25, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Disconnection” (1 report).
4 other recalls cover devices cleared under the same FDA submission (K103658); 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.
Most reported problems
Device problems
- Disconnection1
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.
MalfunctionApr 25, 2023Disconnection; Disconnection
IT WAS REPORTED THAT, "THE DOCTOR FOUND TUBE DISCONNECTED WHEN USING ON PATIENT. THEN CHANGED NEW ONE, NO IMPACT ON PATIENT". ADDITIONAL INFORMATION RECEIVED INDICATES THE SNAPLOCK WAS FOUND DISCONNECTED AND THE WHOLE DEVICE WAS REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16806416 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K103658. One submission often covers many models, so check the product and lot details in each record.
- Z-2364-2026 · Apr 21, 2026 · Open, ClassifiedDescription/REF: ACCESS TRAY/ASK-04001-SUH-S; ACCESS TRAY/ASK-04001-VM1; STIMUCATH SFTY KIT: 19G CTH, 17Gx4CM NDL/AB-19604-KS; STIMUCATH SFTY KIT: 19G CTH, 17Gx8CM NDL/AB-19608-KS;
- Z-1179-2020 · Jan 15, 2020 · TerminatedFlexTip Plus Epidural Catheterization Kit, Product Code ASK-05400-CA1
- Z-1962-2018 · Apr 11, 2018 · TerminatedSnapLock" Catheter/Syringe Adapter; Product Code: AS-05500
- Z-2462-2015 · Jul 30, 2015 · TerminatedPICC Kits with Peel-Away Sheath Component; catheter, intravascular, therapeutic, ultrasound Product Usage: catheter, intravascular, therapeutic, ultrasound
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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