Z-0987-2014Class II

SAFSITE Injection Sites and IV Sets manufactured with SAFSITE Injection Sites. A device used to administer...

Name: Z-0987-2014 SAFSITE Injection Sites and IV Sets manufactured with SAFSITE Injection Sites. A device used to administer...
Creator: B. Braun Medical, Inc.
Published: 2014-01-08
License: https://open.fda.gov/license/

B Braun Medical Inc / initiated 2014-01-08 / Terminated / root cause: manufacturing process

FDA source

B. Braun Medical, Inc. began a recall of 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... on 2014-01-08. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0987-2014
Classification: Class II
Status: Terminated
Initiated: 2014-01-08
Posted: 2014-02-18
Terminated: 2014-11-03
Recalling firm: B Braun Medical Inc
Product: 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.
Product code: FPA Set, Administration, Intravascular
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: A recall notification letter, dated January 7, 2014, was sent to Users and distributors.
Quantity in commerce: 2,357,944
Distribution: Nationwide Distribution.
Product codes and lots: Catalog #351559: batch #s 0061339694, exp. 9/30/2018, 0061338909,exp. 9/30/2018, 0061333582, exp. 8/31/2018; catalog # 352016, batch # 0061326956, exp. 10/31/2018; catalog # 352079, batch #0061333591, exp. 8/31/2018; catalog #352448, batch # 0061334116, exp.9/30/2018; catalog #473017, batch #0061332459, exp. 8/31/2018; catalog # 473017, batch #061335025, exp. 9/30/2018; catalog #473309, batch #s 0061343285, exp. 10/31/2018; calatog #473309, lot #061329867, exp. 9/30/2018, 0061339741, exp. 9/30/2018, 0061333662, exp. 8/31/2018; catalog #474563, batch #s 0061338023, exp. 10/31/2018, 0061333063, exp. 8/31/2018; catalog #490028, batch # 0061324733, exp. 8/31/2018; catalog #490213, batch #s 0061330803, 9/30/2015, 0061345558, exp. 11/30/2015; catalog # SS3140, batch # 0061339123, exp. 9/30/2015; catalog #7B0110, batch #s61315790, 61315791, 61317168, 61317170, 61318428, 61318430, 61318850, 61322303,61326405, 61327038, 61330199, 61331458, all NonSterile, No Expiration Date; catalog # 7B3179, batch #s 61313363, 61314531, 61314532, 61314535, 61330221, all NonSterile, No Expiration Date; catalog #7B3240, batch #s 61324238, exp. 8/31/2018; 61329535, exp. 9/30/2018; 61336490, exp. 7/31/2018; catalog # S5401118N, batch #0061335969, Bulk Non-Sterile, No Expiration Date; and catalog #S5401150N, batch #61326267, NonSterile; No Expiration Date.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0987-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0987-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-26	2014-02-18

Product code FPA

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)