Medical Device Recall: Z-0030-2007

FDA Recalls dataset · Firm: Arrow International Inc · Status: Terminated

Recall Action Class: N/A Date Initiated: 2006-06-20 Recall record compiled from public FDA source records.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0030-2007.

Recall Res Number
Z-0030-2007
Recalling Firm / Manufacturer
Arrow International Inc
FEI Number
3015859709
Recall Status
Terminated
Recall Classification
N/A
Date Initiated
2006-06-20
Date Posted
2006-10-12
Date Terminated
2006-10-16
Product Code
NVM
Event Number
35959
Product Quantity
11 units
Product Description Arrow Double-Lumen Balloon Wedge Pressure Catheter, for sampling blood for oxygen levels and measuring pressures in the right heart.
Reason for Recall The print identifying the two extension lines, CVP Proximal and PA Distal, are reversed.
Action Details Recall letter was sent to customers on 6/20/2006 by US mail.
Distribution Pattern Medical facilities located in MD, IL, MO, MA and United Kingdom, for a total of 5.
Code Information / Serial Numbers MF5124329

Related Establishments / Registrations

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