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Terminated

SAFSITE Injection Sites and IV Sets manufactured with SAFSITE Injection Sites. A device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein.

FDA Recall Z-0987-2014 · Posted 2014-02-18

Recalling FirmB. Braun Medical, Inc.
Recall StatusTerminated
Product CodeFPA
Date Initiated2014-01-08
Date Terminated2014-11-03
Product Quantity2,357,944

Reason for Recall

Complaints were received reporting leakage on certain lots of SAFSITE Injection Sites and IV Sets manufactured with SAFSITE Injection Sites.The SAFSITE Injection Site is intended to provide needle free access on IV and Extension Sets.

Firm Action

A recall notification letter, dated January 7, 2014, was sent to Users and distributors.

Root Cause

Process control

Distribution Pattern

Nationwide Distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K060231CLOSED SWABABLE STOPCOCK AND MINIMAL RESIDUAL VOLUME LUER-ACTIVATED SWABABLE-STOPCOCKElcam Medical Acal · 2006-04-13K955585V2 INJECTION SITEB.Braun Medical, Inc. · 1996-05-15K954123LOW PROFILE SAFSITE Y-SITEB.Braun Medical, Inc. · 1995-11-21K942988FILTERED EXTENSION SETSB. Braun of America, Inc. · 1995-07-14K760383STOPCOCKSB. 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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