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Terminated

Baxter CAPD Solution Transfer Set for use with UV-Flash Germicidal Exchange Device, 1.2 m (48''); a sterile set consisting of a bag connector (spike connector), on-off clamp assembly, tubing and double sealing male Luer lock connector; Baxter Healthcare Corporation, Renal Division, McGaw Park, IL 60085; product code R5C4325

FDA Recall Z-0301-05 · Posted 2004-12-09

Recalling FirmBaxter Healthcare Renal Div
Recall StatusTerminated
Product CodeKDJ
Date Initiated2004-11-05
Date Terminated2006-05-16
Product Quantity1,152 sets

Reason for Recall

Disconnection of the tubing at the clamp level of the UV Flash Transfer Set.

Firm Action

Recall by letter dated 11/05/04. The customers were instructed to stop using this lot of product, return any stocks of the lot back to Baxter, and that replacement of the patient''s set be completed at the dialysis center.

Root Cause

Other

Distribution Pattern

The entire lot was distributed overseas to Belgium, Sweden, Norway, the United Kingdom, Germany and France.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K883239CAPD ULTRAVIOLET(U.V.) GERMICIDAL EXCHANGE DEV SYSBaxter Healthcare Corp · 1988-10-21

Official Source

View FDA Recall →

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

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