Reported May 6, 2015 · Terminated
9F Plastic Dual Port; The port systems are totally implantable vascular access devices. They consist of an injection…
Medical Components, Inc. dba MedComp
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medical Components, Inc dba MedComp · 1499 Delp Dr · Harleysville, PA · 19438
Is this the product you have?
- 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 ofmedications, intravenous fluids, blood products, parenteral nutrition, and for venous blood sampling
- Lot codes and dates
Model No. MR592090AMR592090Pwith Lot Nos.: MAKT120 EXP. DATE 04/28/2012MAXH410 EXP. DATE 06/28/2014MAXF610 EXP. DATE 10/28/2014MBFC140 EXP. DATE 05/28/2016MBGH020 EXP. DATE 08/28/2016MBHS100 EXP. DATE 11/28/2016MAKT130 EXP. DATE 04/28/2012MBAQ860 EXP. DATE 07/28/2015MBHP980 EXP. DATE 11/28/2016MBKJ110 EXP. DATE 03/28/2017
- Amount recalled
- 325
Where it was sold
- Nationwide
Why it was recalled
The dual port with catheters was not covered under FDA clearance.
This product could cause temporary or reversible health problems — stop using it.
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