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Terminated

10 FR Super Arrow-Flex Percutaneous Sheath Introducer Set

FDA Recall Z-0088-04 · Posted 2003-11-01

Recalling FirmArrow International Inc
Recall StatusTerminated
Product CodeKZH
Date Initiated2003-10-22
Date Terminated2004-04-05
Product Quantity80 units

Reason for Recall

package lid identifies the contents incorrectly

Firm Action

The recalling firm notified the consignees via telephone on 10/22/03 regarding the problem and the need to return the product.

Root Cause

Other

Distribution Pattern

The products were shipped to medical facilities in AR, CA, NH, VA and VT. The product was also shipped to a distributor in Srialanka

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K924607ARROW FISCHELL KINK RESIST PERCUT SHEATH INTRO SETArrow Intl., Inc. · 1993-04-22

Official Source

View FDA Recall →

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

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