Medical Device Recall: Z-0017-05

FDA Recalls dataset · Firm: Fresenius Medical Care North America · Status: Terminated

Recall Action Class: N/A Date Initiated: 2004-09-20 Recall record compiled from public FDA source records.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0017-05.

Recall Res Number
Z-0017-05
Recalling Firm / Manufacturer
Fresenius Medical Care North America
FEI Number
3001451489
Recall Status
Terminated
Recall Classification
N/A
Date Initiated
2004-09-20
Date Posted
2004-10-13
Date Terminated
2006-06-28
Product Code
KDJ
Event Number
30007
Product Quantity
3,510 units
Product Description Fresenius Peritoneal Dialysis Premier Luer Lock Transfer Set 8'', Sterile with Female Safe Lock Connector Luer Lock and Slide Clamp Catalog Number: 050-30034
Reason for Recall Peritoneal Dialysis Transfer Set may have occluded pathway
Action Details Fresenius Medical is conducting telephone contact to the dialysis clinics starting 9/20/04 and follow-up with a notice to be mailed o/a 9/27/04.Clinics are requested to examine inventory for lot numbers and return unused product to Fresenius.
Distribution Pattern Nationwide Canada: Fresenius Medical Care Canada 258 East Pearce Street, Richmond Hill, ON
Code Information / Serial Numbers Lot Numbers: 3LR240, 3NR190, 3SR074, 4AR119, 4BR187, 4CR290

Related Establishments / Registrations

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