FDA Device recall Z-1300-2014
PowerPort Slim Implantable Port, indicated for patient therapies requiring repeated access to the vascular system
- FDA Device
- Class II
- terminated
- Published 2014-04-02
On 2014-04-02 the FDA classified a Class II recall of PowerPort Slim Implantable Port, indicated for patient therapies requiring repeated access to the vascular system by Bard Access Systems, citing 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 PowerP….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1300-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-02-27 |
| Published | 2014-04-02 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Bard Access Systems |
| Distribution | US |
Product
PowerPort Slim Implantable Port, indicated for patient therapies requiring repeated access to the vascular system. Product Codes: 1716000, 1716070
Reason
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.
Identifiers
| code_info | Lot Numbers: REXA1302, REXA1350, REXB1160 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1300-2014%22
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