MedComp Recalls 9F Plastic Dual Port Vascular Access Devices
Medical Components, Inc. is recalling 325 units of 9F Plastic Dual Port vascular access devices because they were not covered under FDA clearance.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically corresponds to a moderate severity level. The source text does not report any specific injuries, illnesses, or deaths, and the hazard is primarily regulatory (lack of clearance) rather than a confirmed physical defect causing harm.
Plain-English summary
Medical Components, Inc. dba MedComp is recalling 325 units of 9F Plastic Dual Port totally implantable vascular access devices. These devices consist of an injection port, a self-sealing membrane, and a detachable catheter, and are used for the delivery of medications, intravenous fluids, blood products, parenteral nutrition, and for venous blood sampling.
The recall was initiated because the dual port with catheters was not covered under FDA clearance. The affected products are Model No. MR592090A and MR592090P, distributed worldwide including the US, Canada, Brazil, and the United Arab Emirates.
Healthcare providers and patients should contact Medical Components, Inc. for further instructions regarding the return or replacement of these devices.
The recalled product
- 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, intrave
- Manufacturer
- Medical Components, Inc dba MedComp
- Category
- Medical Device — Vascular Access
- Affected units
- 325
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (12)
- 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
Distribution
Distributed nationwide across the United States.
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