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Terminated

12 French 3 Lumen 16 cm Large-Bore Central Venous Catheters. Product numbers AK-12123-H, CS-12123-E, MA-12123, and MC-12123. 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.

FDA Recall Z-1671-2009 · Posted 2009-08-10

Recall StatusTerminated
Product CodeFOZ
Date Initiated2009-05-08
Date Terminated2010-07-29
Product Quantity46,610 total

Reason for Recall

Wire guide can have difficulty passing through catheter juncture hub or being removed from the catheter.

Firm 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.

Root Cause

Nonconforming Material/Component

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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