Medical Device Recall: Z-0031-04

FDA Recalls dataset · Firm: N/A · Status: Terminated

Recall Action Class: N/A Date Initiated: 2003-08-20 Recall record compiled from public FDA source records.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0031-04.

Recall Res Number
Z-0031-04
Recalling Firm / Manufacturer
N/A
FEI Number
3002095335
Recall Status
Terminated
Recall Classification
N/A
Date Initiated
2003-08-20
Date Posted
2003-10-15
Date Terminated
2005-10-24
Product Code
LOX
Event Number
27231
Product Quantity
6 catheters
Product Description Ace Percutaneous Transluminal Coronary Angioplasty (PTCA) Dilatation Catheter with 2cm Tip 20 mm Balloon, Catalog Number H74902071051
Reason for Recall Some of the recalled catheters have a component that has levels of pyrogens above specification.
Action Details Consignees were sent a recall letter dated August 20, 2003. The letter requested that consignees discontinue use of the catheters from the affected lots and return them.
Distribution Pattern The recalled products were distributed to consignees located nationwide in the United States.
Code Information / Serial Numbers Lots 5685024 and 5685027

Related Establishments / Registrations

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