Z-0114-2015Class II

ASK-05501-AFH1, Lot Number 23F13K0969 Anesthesia Conduction Catheter, Epidural Anesthesia Kit

Name: Z-0114-2015 ASK-05501-AFH1, Lot Number 23F13K0969 Anesthesia Conduction Catheter, Epidural Anesthesia Kit
Creator: Arrow International Inc
Published: 2014-09-15
License: https://open.fda.gov/license/

Arrow International LLC (subsidiary of Teleflex Incorporated) / initiated 2014-09-15 / Terminated / root cause: labeling and UDI

FDA source

Arrow International Inc began a recall of ASK-05501-AFH1, Lot Number 23F13K0969 Anesthesia Conduction Catheter, Epidural Anesthesia Kit on 2014-09-15. FDA classified it as Class II and gives the reason as "Arrow International, Inc. is notifying customers that lot 23F13K0969 of product code ASK-05501-AFH1 contains an incorrect component. The lidstock indicates that the kit contains one Syringe, 10mL, Luer-Slip Loss of...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0114-2015
Classification: Class II
Status: Terminated
Initiated: 2014-09-15
Posted: 2014-10-22
Terminated: 2015-12-18
Recalling firm: Arrow International LLC (subsidiary of Teleflex Incorporated)
Product: ASK-05501-AFH1, Lot Number 23F13K0969 Anesthesia Conduction Catheter, Epidural Anesthesia Kit
Product code: CAZ Anesthesia Conduction Kit
Reason for recall: Arrow International, Inc. is notifying customers that lot 23F13K0969 of product code ASK-05501-AFH1 contains an incorrect component. The lidstock indicates that the kit contains one Syringe, 10mL, Luer-Slip Loss of Resistance, Glass but contains one Syringe, 10mL, Luer-Lock Loss of Resistance, Glass.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: Arrow International sent a Medical Device Advisory Notification dated September 15, 2014, to affected customers notifying them that lot 23F13K0969 of product code ASK-05501-AFH1 contains an incorrect component, and requesting they provide this Advisory Notice to all those who need to be aware of it within your organization. Questions were directed to local sales representative or Customer Service at 1-866-246-6990.
Quantity in commerce: 300
Distribution: US Distribution in Utah only.
Product codes and lots: Catalog No. ASK-05501-AFH1 Lot Number 23F13K0969

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0114-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0114-2015	Class II	Terminated	Voluntary: Firm initiated	2014-10-29	2014-10-22

Product code CAZ

K001587Class II19 Ga Plastic Reinforced Epidural CatheterArrow Intl., Inc. / cleared 2000-07-12

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)