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Terminated

Gravity and Infusion Pump Intravenous (IV) Sets using the Y-site Ultrasite Valve including: Horizon Pump IV Sets; Vista Pump IV Sets; Primary IV Sets; Blood Sets; Burette Sets; Filtered Administration Sets; Extension Sets; Anesthesia Sets; Rate Flow Extension Sets; and Rate Flow IV Administration Sets.

FDA Recall Z-0933-03 · Posted 2003-06-12

Recalling FirmBraun,B Medical Inc
Recall StatusTerminated
Product CodeFPA
Date Initiated2003-04-14
Date Terminated2004-01-29
Product Quantity2577300 units

Reason for Recall

possible leakage

Firm Action

The recalling firm sent recall letters to their direct accounts dated 4/14/03. The recall letters inform the accounts of the problem and the need to return the product.

Root Cause

Other

Distribution Pattern

The products were shipped to medical facilities and distributors nationwide. The products were also shipped to the firm''s German facility, Canada and Spain.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K955585V2 INJECTION SITEB.Braun Medical, Inc. · 1996-05-15K942988FILTERED EXTENSION SETSB. Braun of America, Inc. · 1995-07-14K943770LOW VOLUME MULTIPORTB. Braun of America, Inc. · 1995-04-10K790062IV ADMINISTRATION SET WITH BACKCHECKNational Patent Development Corp. · 1979-04-10K760383STOPCOCKSB. Braun Instruments · 1976-11-02

Official Source

View FDA Recall →

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

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