PlainRecalls
FDA Devices Moderate Class II 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.

Reported: February 26, 2014 Initiated: January 8, 2014 #Z-0987-2014

Product Description

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.

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.

Details

Recalling Firm
B. Braun Medical, Inc.
Units Affected
2,357,944
Distribution
Nationwide Distribution.
Location
Allentown, PA

Frequently Asked Questions

What product was recalled?
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.. Recalled by B. Braun Medical, Inc.. Units affected: 2,357,944.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on February 26, 2014. Severity: Moderate. Recall number: Z-0987-2014.