9F Plastic Dual Port — Class II medical device recall Z-1527-2015
Terminated recall by Medical Components, Inc dba MedComp, reported 2015-05-06, distributed nationwide. The dual port with catheters was not covered under FDA clearance.
| Recall number | Z-1527-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medical Components, Inc dba MedComp, Harleysville, PA, United States |
| Recall initiated | 2015-01-28 |
| Classified | 2015-04-27 |
| Reported by FDA | 2015-05-06 |
| Terminated | 2017-01-06 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, BR, CA |
| Quantity | 325 |
| Lot numbers | MAKT120, MAKT130, MAXF610, MAXH410, MBAQ860, MBFC140, MBGH020, MBHP980, MBHS100, MBKJ110 |
| Model numbers | MR592090A, MR592090P |
| Expiration dates | 2012-04-28, 2014-06-28, 2014-10-28, 2015-07-28, 2016-05-28, 2016-08-28, 2016-11-28, 2017-03-28 |
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 for recall
The dual port with catheters was not covered under FDA clearance.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1527-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.