Z-1300-2014Class II

PowerPort Slim Implantable Port, indicated for patient therapies requiring repeated access to the vascular...

Name: Z-1300-2014 PowerPort Slim Implantable Port, indicated for patient therapies requiring repeated access to the vascular...
Creator: Bard Access Systems
Published: 2014-02-27
License: https://open.fda.gov/license/

Bard Access Systems, Inc. / initiated 2014-02-27 / Terminated / root cause: packaging

FDA source

Bard Access Systems began a recall of PowerPort Slim Implantable Port, indicated for patient therapies requiring repeated access to the vascular system. Product Codes: 1716000, 1716070 on 2014-02-27. FDA classified it as Class II and gives the reason as "Labeling discrepancy.The label states that the implantable port contains silicone suture plugs, however approximately 23% of the units contained in the affected lots have a PowerPort Slim titanium implantable port...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1300-2014
Classification: Class II
Status: Terminated
Initiated: 2014-02-27
Posted: 2014-03-27
Terminated: 2014-09-05
Recalling firm: Bard Access Systems, Inc.
Product: PowerPort Slim Implantable Port, indicated for patient therapies requiring repeated access to the vascular system. Product Codes: 1716000, 1716070
Product code: LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
Reason for recall: Labeling discrepancy.The label states that the implantable port contains silicone suture plugs, however approximately 23% of the units contained in the affected lots have a PowerPort Slim titanium implantable port without silicone suture plugs.
Root cause tag: packaging
FDA root cause: Packaging
Action: Notified by Urgent Customer Notification Letter date February 13, 2014, customers were asked to immediately examine their inventory and identify any product subject to this notification. In addition, if they have further distributed this product, please identify customers and notify them at once of this notification. Customers may include a copy of this letter in your notification to customers. Customers may choose to use the involved product with the understanding that the kit may contain a PowerPort Slim implantable port without suture plugs, or may return the applicable product for replacement or credit.
Quantity in commerce: 777
Distribution: US Nationwide distribution including WA, KY, IL, and IA.
Product codes and lots: Lot Numbers: REXA1302, REXA1350, REXB1160

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1300-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1300-2014	Class II	Terminated	Voluntary: Firm initiated	2014-04-02	2014-03-27

Product code LJT

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)