Z-1300-04

ARROW EPIDURAL CATHETERIZATION KIT. Product No. MC-05001

Name: Z-1300-04 ARROW EPIDURAL CATHETERIZATION KIT. Product No. MC-05001
Creator: Arrow International Inc
Published: 2004-06-07
License: https://open.fda.gov/license/

Arrow International LLC (subsidiary of Teleflex Incorporated) / initiated 2004-06-07 / Terminated / root cause: packaging

FDA source

Arrow International Inc began a recall of ARROW EPIDURAL CATHETERIZATION KIT. Product No. MC-05001 on 2004-06-07. The reason FDA records is "The recall is due to a confirmed packaging error of the wrong epidural needle (longer than stated)". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1300-04
Status: Terminated
Initiated: 2004-06-07
Posted: 2004-07-31
Terminated: 2004-09-21
Recalling firm: Arrow International LLC (subsidiary of Teleflex Incorporated)
Product: ARROW EPIDURAL CATHETERIZATION KIT. Product No. MC-05001.
Product code: CAZ Anesthesia Conduction Kit
Reason for recall: The recall is due to a confirmed packaging error of the wrong epidural needle (longer than stated).
Root cause tag: packaging
FDA root cause: Other
Action: The recalling firm sent a recall letter to its direct accounts to notify of the recall action and that the wrong epidural needle was packaged in the kits. The letter instructed the accounts to returned the kits to the recalling firm''s Asheboro, NC facility for rework and resterilization.
Quantity in commerce: 270 units
Distribution: The recalled kits with the wrong epidural needle was distributed to the following direct accounts, to the following states in TN and TX
Product codes and lots: Lot No. RF4044686, expiration date 2006-09

Product code CAZ

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)