12 French 3 Lumen 16 cm Large-Bore Central Venous Catheters. Product numbers AK-12123-H, CS-12123-E, MA-12123, and MC-12
FDA device recall Z-1671-2009 · posted 2009-08-10 · Terminated
Recall details
- Recalling firm
- Arrow International Inc
- Reason for recall
- Wire guide can have difficulty passing through catheter juncture hub or being removed from the catheter.
- Action taken
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- FOZ
- Quantity affected
- 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,
- Date initiated
- 2009-05-08
- Date posted
- 2009-08-10
- Date terminated
- 2010-07-29
- Location
- Reading, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ARROW-HOWES LARGE BORE MULTI-LUMEN CENTRAL VENOUS CATHETERS (K970864) | Arrow Intl., Inc. | 1997-10-17 |