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Recall Observatory FDA recall evidence

Device 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.

Z-1527-2015

January 28, 2015

Class II

Product summary

Firm
Medical Components, Inc dba MedComp
Event
Event 70457
Status
Terminated
Classification
Class II
Quantity
325
Official record key
device-enforcement:Z-1527-2015

Official wording

Reason: The dual port with catheters was not covered under FDA clearance.

Code information: 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 pattern: Worldwide distribution. US nationwide, Canada, Brazil, and United Arab Emirates.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The dual port with catheters was not covered under FDA clearance.