FDA Medical Device Recalls (openFDA)
Arrow International Inc: 12 French 3 Lumen 20 cm Large-Bore Central Venous Catheters. Product numbers AK-15123-H, AK-15123-J, CS-15123-E, and MC-15123. The large-bore multiple-lumen catheter permits venous access to the central circulation for rapid fluid administration. It may be inserted into the jugular, subclavian, or femoral veins.
- Recall number
- Z-1672-2009
- Recalling firm
- Arrow International Inc
- Product
- 12 French 3 Lumen 20 cm Large-Bore Central Venous Catheters. Product numbers AK-15123-H, AK-15123-J, CS-15123-E, and MC-15123. The large-bore multiple-lumen catheter permits venous access to the central circulation for rapid fluid administration. It may be inserted into the jugular, subclavian, or femoral veins.
- Status
- Terminated
- Initiated
- 2009-05-08
- Posted
- 2009-08-10
- Terminated
- 2010-07-29
- Reason
- Wire guide can have difficulty passing through catheter juncture hub or being removed from the catheter.
- Root cause
- Nonconforming Material/Component
- Action
- The recalling firm issued an Urgent Medical Device Recall letter dated 5/11/09 to their customers informing them of the problem and the potential consequences. The letter asked customers to check their stock, cease use and distribution, and quarantine the affected products. They are to contact Arrow's Customer Service Department at 1-800-523-8446 for a Return Authorization Number; complete the Recall Acknowledgement & Stock Status Form and fax to 1-800-343-2935; and return any affected product. The letter states that Arrow can provide either replacement with a similar product at no charge or credit customers' accounts. Additional information or clarification can be obtained by calling Customer Service at 1-800-523-8446.
- Quantity
- 46,610 total
- Distribution
- Worldwide Distribution -- USA, Belgium, Canada, Cyprus, Czech Republic, Estonia, Finland, France, Germany, Hungary, Indonesia, Ireland, Israel, Italy, Lithuania, Japan, Republic of Korea, Netherlands, New Zealand, Poland, Singapore, Slovakia, South Africa, Spain, Taiwan, Ukraine, and United Kingdom.
- Lot, serial or model codes
- Product numbers AK-15123-H - Lot numbers: RF8020142, RF8029122, RF8031799, RF8045050, RF8084251, RF8123397, RF9027126, and RF9039409; Product numbers AK-15123-J - Lot numbers: RF8031856, RF8056908, and RF8071778; Product numbers CS-15123-E - Lot numbers: RF8044326, RF8071238, RF8097152, RF9014658, RFZF8027313, ZF8027652, ZF8037872, ZF8048327, ZF8058745, ZF8069575, ZF8070317, ZF8079993, ZF8080559, ZF8091380, ZF8113337, ZF8123891, ZF9014736, ZF9014737, ZF9014797, ZF9025529, ZF9035668; and Product numbers MC-15123 - Lot numbers: RF8044327, RF8069574, RF8084830, RF9016649, and RF9039995.
- 510(k) numbers
- ["K970864"]
- PMA numbers
- not on file
- Product code
- FOZ
- 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