Z-2671-2011

B. Braun Celsite Venous Access Ports , Distributed by Aesculpa Inc. Model ST301, ST305V, ST301G, ST501G and...

Name: Z-2671-2011 B. Braun Celsite Venous Access Ports , Distributed by Aesculpa Inc. Model ST301, ST305V, ST301G, ST501G and...
Creator: B. Braun Interventional Systems
Published: 2011-04-13
License: https://open.fda.gov/license/

B. BRAUN INTERVENTIONAL SYSTEMS Inc. / initiated 2011-04-13 / Terminated / root cause: manufacturing process

FDA source

B. Braun Interventional Systems began a recall of B. Braun Celsite Venous Access Ports , Distributed by Aesculpa Inc. Model ST301, ST305V, ST301G, ST501G and ST315 Reference # Model # 04430425 ST301 04430095... on 2011-04-13. The reason FDA records is "The affected products contain the incorrect winged Surecan needle accessory component in certain Celsite Access Port package configurations. The winged Surecan needle is used to deliver medications and fluids into...". 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-2671-2011
Status: Terminated
Initiated: 2011-04-13
Posted: 2011-06-27
Terminated: 2012-07-06
Recalling firm: B. BRAUN INTERVENTIONAL SYSTEMS Inc.
Product: B. Braun Celsite Venous Access Ports , Distributed by Aesculpa Inc. Model ST301, ST305V, ST301G, ST501G and ST315 Reference # Model # 04430425 ST301 04430095 ST305V 04433823 ST301G 04437025 ST501G 04436725 ST315
Product code: LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
Reason for recall: The affected products contain the incorrect winged Surecan needle accessory component in certain Celsite Access Port package configurations. The winged Surecan needle is used to deliver medications and fluids into implanted Celsite Access Ports. Two winged Surecan needle sizes are provided in Celsite U.S. package configurations: 20G (PN 4058631) or 22G (PN 16006593A). A 20G or 22G needle
Root cause tag: manufacturing process
FDA root cause: Process design
Action: B.Braun Interventional Systems Inc, (BIS) sent a "Urgent Medical Device Recall" letter on April 16, 2011 to all affected customers. The letter described the problem and the product involved in the recall. Informed consignees that their local B.Braun Interventional System Inc Product Specialists will contact them with the specifics for return/replacement of the product upon return of qualified removed product. They also requested that a Celsite Access Port Patient Implant Form be filled out for each patient implanted with one of the Celsite Access Ports from the affected lots. This Form to be provided to them by their local BIS Product Specialist. For additional information contact 800 523-9676 x4459.
Quantity in commerce: 83
Distribution: NY, ND, OK ,PA
Product codes and lots: Reference # Model # Lot # 04430425 ST301 J313196U 04430095 ST305V J312177U 04433823 ST301G J313197U K021193U 04437025 ST501G J312178U 04436725 ST315 J295789U

Product code LJT

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)