Z-1012-2011

Arrow WH-02220 - Epidural Catheterization Kit with FlexTip Plus(R) Catheter

Name: Z-1012-2011 Arrow WH-02220 - Epidural Catheterization Kit with FlexTip Plus(R) Catheter
Creator: Arrow International Inc
Published: 2010-11-11
License: https://open.fda.gov/license/

Arrow International LLC (subsidiary of Teleflex Incorporated) / initiated 2010-11-11 / Terminated / root cause: manufacturing process

FDA source

Arrow International Inc began a recall of Arrow WH-02220 - Epidural Catheterization Kit with FlexTip Plus(R) Catheter Intended use: Permits acccess to epidural space, Epidural Anesthesia Kit on 2010-11-11. The reason FDA records is "Sterility may be compromised". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1012-2011
Status: Terminated
Initiated: 2010-11-11
Posted: 2011-02-01
Terminated: 2012-07-05
Recalling firm: Arrow International LLC (subsidiary of Teleflex Incorporated)
Product: Arrow WH-02220 - Epidural Catheterization Kit with FlexTip Plus(R) Catheter Intended use: Permits acccess to epidural space, Epidural Anesthesia Kit
Product code: CAZ Anesthesia Conduction Kit
Reason for recall: Sterility may be compromised.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: The firm, Arrow International, issued an "URGENT MEDICAL DEVICE RECALL" letter dated November 11, 2010 to their consignees/customers. The letter described the product, problem and action to be taken by the customers. The customers were instructed to check their inventory for the affected products, cease use and distribution, quarantine all affected product immediately, return any affected product freight collect along with the completed form via mail to: Arrow International, Inc., 312 Commerce Place, Asheboro, NC 27203, Attn: Asheboro Quality Assurance Manager, and complete and return the FIELD SAFETY CORRECTIVE ACTION ACKNOWLEDGEMENT AND STOCK STATUS FORM via fax to: 800-343-2935. If you require additional information or clarification regarding this matter, please contact your sales representative, or Arrow's Customer Service Department at 866-396-2111.
Quantity in commerce: 2320
Distribution: Nationwide Distribution: USA states including IL and LA.
Product codes and lots: Lot # RF0063961

Product code CAZ

K884552Class IIContinuous Epidural Anesthesia Kit W/poly CatheterArrow Intl., Inc. / cleared 1989-03-14

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)