FDA Medical Device Recalls (openFDA)
Arrow International Inc: Arrow WH-02220 - Epidural Catheterization Kit with FlexTip Plus(R) Catheter Intended use: Permits acccess to epidural space, Epidural Anesthesia Kit
- Recall number
- Z-1012-2011
- Recalling firm
- Arrow International Inc
- Product
- Arrow WH-02220 - Epidural Catheterization Kit with FlexTip Plus(R) Catheter Intended use: Permits acccess to epidural space, Epidural Anesthesia Kit
- Status
- Terminated
- Initiated
- 2010-11-11
- Posted
- 2011-02-01
- Terminated
- 2012-07-05
- Reason
- Sterility may be compromised.
- 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
- 2320
- Distribution
- Nationwide Distribution: USA states including IL and LA.
- Lot, serial or model codes
- Lot # RF0063961
- 510(k) numbers
- ["K884552"]
- PMA numbers
- not on file
- Product code
- CAZ
- Firm FEI
- 3015859709
- Firm city
- Reading
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28