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Terminated

Fresenius Peritoneal Dialysis Premier Luer Lock Transfer Set 8'', Sterile with Female Safe Lock Connector Luer Lock and Slide Clamp Catalog Number: 050-30034

FDA Recall Z-0017-05 · Posted 2004-10-13

Recalling FirmFresenius Medical Care North America
Recall StatusTerminated
Product CodeKDJ
Date Initiated2004-09-20
Date Terminated2006-06-28
Product Quantity3,510 units

Reason for Recall

Peritoneal Dialysis Transfer Set may have occluded pathway

Firm Action

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.

Root Cause

Other

Distribution Pattern

Nationwide Canada: Fresenius Medical Care Canada 258 East Pearce Street, Richmond Hill, ON

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K822550SAFE LOCK TITANIUM ADAPTER SETAmerican Medical Products, Inc. · 1982-10-13

Official Source

View FDA Recall →

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

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