CLASS II Device recall · Reported 15 Oct 2014 · FDA Enforcement Report

BioFlo PICC with Endexo Technology Maximal Barrier Nursing recalled

Navilyst Medical is recalling BioFlo PICC with Endexo Technology Maximal Barrier Nursing Kit, 5F-, Upn Product No, distributed nationwide in the US. The recall was initiated on 25 Aug 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesBatch/Lot No. 4752351 (exp. 31-Jan-16)

Quantity recalled65 units/pouches

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0027-2015
FDA event ID: 69085
Recalling firm: Navilyst Medical, Glens Falls, NY
Classification: Class II
Status: Terminated
Recall initiated: 25 Aug 2014
FDA classified: 6 Oct 2014
Reported: 15 Oct 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Labeling Errors
Device type: Patient Monitors

Timeline

25 Aug 2014	Recall initiated by company
6 Oct 2014	Classified by FDA	+42 days
15 Oct 2014	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it had initiated a recall on specific lots of the syringes as some syringe unit packages exhibited open seals which may impact package integrity and potentially affect product sterility. Based on the notification, NMI is recalling specific PICC Kits that contain the affected 10 ml BD PosiFlush SF Saline Flush Syringes.

Product as listed by the FDA

BioFlo PICC with ENDEXO Technology Maximal Barrier Nursing Kit, 5F-55 cm, UPN Product No. H965750141, REF/Catalog No. 75-014, STERILE --- Intended for short or long term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, nutrients; the sampling of blood, for central venous pressure monitoring and for power injection of contrast media.

Where it was distributed

Nationwide Distribution

Nationwide

Questions about this recall

Is BioFlo PICC with Endexo Technology Maximal Barrier Nursing Kit, 5F-, Upn Product No recalled?

Yes. Navilyst Medical recalled BioFlo PICC with Endexo Technology Maximal Barrier Nursing Kit, 5F-, Upn Product No on 25 Aug 2014. The recall is Class II and its status is Terminated. Recall number Z-0027-2015.

Why was it recalled?

Which lots are affected?

Batch/Lot No. 4752351 (exp. 31-Jan-16)

Where was it sold?

Nationwide Distribution

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Navilyst Medical

All 73

Reported	Class	Recall	Company	Reason	Where
4 Mar 2015Device	CLASS II	Namic Convenience Kit, Radiology Kit, Upn H749601014911 recalled	Navilyst Medical	Sterility	Nationwide
4 Mar 2015Device	CLASS II	Namic Convenience Kit, Left Heart Kit, Upn H749601113111 recalled	Navilyst Medical	Sterility	Nationwide
4 Mar 2015Device	CLASS II	Namic Convenience Kit, Left Heart Cath Kit, Upn H7496010018151 recalled	Navilyst Medical	Sterility	Nationwide
4 Mar 2015Device	CLASS II	Namic Convenience Kit, Left Heart Kit, Upn H9656002072121 recalled	Navilyst Medical	Sterility	Nationwide
4 Mar 2015Device	CLASS II	Namic Convenience Kit, UPN H965601206511 recalled by Navilyst Medical	Navilyst Medical	Sterility	Nationwide

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2 Sep 2026Device	CLASS II	IQecg Digital ECG recalled by Midmark	Midmark	Labeling Errors	Nationwide
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