FDA Device recall Z-1527-2015
9F Plastic Dual Port
- FDA Device
- Class II
- terminated
- Published 2015-05-06
On 2015-05-06 the FDA classified a Class II recall of 9F Plastic Dual Port by Medical Components, citing the dual port with catheters was not covered under FDA clearance.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1527-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-01-28 |
| Published | 2015-05-06 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Medical Components |
| Distribution | US |
Product
9F Plastic Dual Port; The port systems are totally implantable vascular access devices. They consist of an injection port, a self-sealing membrane and a detachable catheter. The port systems provide repeated vascular access and are applicable for delivery of: medications, intravenous fluids, blood products, parenteral nutrition, and for venous blood sampling.
Reason
The dual port with catheters was not covered under FDA clearance.
Identifiers
| code_info | Model No. MR592090A, MR592090P; with Lot Nos.: MAKT120 EXP. DATE 04/28/2012, MAXH410 EXP. DATE 06/28/2014, MAXF610 E…Model No. MR592090A, MR592090P; with Lot Nos.: MAKT120 EXP. DATE 04/28/2012, MAXH410 EXP. DATE 06/28/2014, MAXF610 EXP. DATE 10/28/2014, MBFC140 EXP. DATE 05/28/2016, MBGH020 EXP. DATE 08/28/2016, MBHS100 EXP. DATE 11/28/2016, MAKT130 EXP. DATE 04/28/2012, MBAQ860 EXP. DATE 07/28/2015, MBHP980 EXP. DATE 11/28/2016, MBKJ110 EXP. DATE 03/28/2017 |
|---|
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-1527-2015%22
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