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Terminated

Baxter System 1000 Tina Single Patient Hemodialysis Delivery System; Baxter Healthcare Corporation, Renal Division, McGaw Park, IL 60085; product code S1000L3P. Hemodialysis and Continuous Renal Replacement Therapy devices for acute and chronic hemodialysis

FDA Recall Z-0173-2012 · Posted 2011-11-07

Recalling FirmBaxter Healthcare Renal Div
Recall StatusTerminated
Product CodeKDI
Date Initiated2011-09-19
Date Terminated2011-11-07
Product Quantity1 unit

Reason for Recall

The Tina System was released to the customer with OOS values for the Pressure Displays Accuracy and Leakage Rate Test.

Firm Action

Baxter Healthcare Corporation sent a service technician to the lone customer site on September 19, 2011 to correct the affected product. The technician executed all tests as established in the Service Manual, with acceptable results.

Root Cause

Employee error

Distribution Pattern

Distributed in Puerto Rico only.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K970446DRAKE WILLOCK SYSTEM & ALTRA TOUCH 1000 DIALYSIS DELIVERY SYSTEMAlthin Medical AB an Affiliate of Baxter Intl · 1997-06-02

Official Source

View FDA Recall →

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

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