Arrow Pediatric Two-Lumen Central Venous Catheterization Set with Blue FlexTip Catheter, 5 Fr., 2 Lumen, 13cm catheter length, Catalog number: CS-14502.
FDA Recall Z-1653-2009 · Posted 2009-07-07
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Recalling FirmArrow International Inc
Recall StatusTerminated
Product CodeDQY
Date Initiated2009-06-17
Date Terminated2009-12-03
Product Quantity3019 units
Reason for Recall
The spring wire guide is too large in diameter to pass through the needle, dilator and catheter.
Firm Action
Arrow notified consignees by letter on/about 06/17/2009. They were instructed to cease use and distribution and quarantine all affected product. They were to contact Arrow's Customer Service Department for a Return Authorization Number. Enclosed was a Recall Acknowledgement & Stock Status Form to be completed and faxed to Arrow International to verify receipt of notification and acknowledge the amount of return.
Root Cause
Process design
Distribution Pattern
Worldwide distribution, including USA, Argentina, Brazil, India, Taiwan and Thailand.
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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