FDA Medical Device Recalls (openFDA)
Arrow International Inc: ARROW EPIDURAL CATHETERIZATION KIT. Product No. MC-05001.
- Recall number
- Z-1300-04
- Recalling firm
- Arrow International Inc
- Product
- ARROW EPIDURAL CATHETERIZATION KIT. Product No. MC-05001.
- Status
- Terminated
- Initiated
- 2004-06-07
- Posted
- 2004-07-31
- Terminated
- 2004-09-21
- Reason
- The recall is due to a confirmed packaging error of the wrong epidural needle (longer than stated).
- 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
- 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
- Lot, serial or model codes
- Lot No. RF4044686, expiration date 2006-09
- 510(k) numbers
- not on file
- 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