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U.S. Department of Health and Human Services

Enforcement Report - Week of June 11, 2014

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Product Detail

Product Description Arrow® Percutaneous Sheath Introducer Kits The Percutaneous sheath introducer products permit venous or arterial access and device introduction to the central circulation.
Recall Number Z-1713-2014
Classification Class II
Code Info Product codes and lot numbers: AK-09903-A 23F13G0162 AK-09903-S RF3064511 CDC-09903-1A 23F13G0642 AK-09903-J 23F13G0400 ASK-09903-CMC RF3064673 NL-09903-S 23F13G0630 AK-09903-LFSP RF3065449 ASK-09903-CMC 23F13G0343 NR-09903-S 23F13G0180 AK-09903-S 23F13G0204 ASK-09903-NKC 23F13G0336 SI-09903-E RF3064710 AK-09903-S RF3064956 ASK-09903-TJ 23F13G0567 SI-09903-E RF3064915 AK-09903-S 23F13H0195 CDC-09903-1A RF3065316
Product Distributed Qty 15424
Reason For Recall Arrow is recalling the Arrow® Percutaneous Sheath Introducer Kits due to dilator tip damage noted during internal inspection. Dilator tip damage has the potential to result in vessel damage.

Event Detail

Event Id 68073
Product Type Devices
Status Ongoing
Recalling Firm Arrow International Inc
City Reading
State PA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2014-04-14
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Worldwide Distribution - USA (nationwide) and Canada.