FDA Medical Device Recalls (openFDA)
Arrow International Inc: ASK-05501-AFH1, Lot Number 23F13K0969 Anesthesia Conduction Catheter, Epidural Anesthesia Kit
- Recall number
- Z-0114-2015
- Recalling firm
- Arrow International Inc
- Product
- ASK-05501-AFH1, Lot Number 23F13K0969 Anesthesia Conduction Catheter, Epidural Anesthesia Kit
- Status
- Terminated
- Initiated
- 2014-09-15
- Posted
- 2014-10-22
- Terminated
- 2015-12-18
- Reason
- 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
- 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
- 300
- Distribution
- US Distribution in Utah only.
- Lot, serial or model codes
- Catalog No. ASK-05501-AFH1 Lot Number 23F13K0969
- 510(k) numbers
- ["K001587"]
- 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