Reported Jun 24, 2020 · Terminated
BioFlo Midline Catheter and BioFlo Maximal Barrier Kits - Product Usage: These introducers are used for the…
Angiodynamics, Inc.
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: Angiodynamics, Inc. · 603 Queensbury Ave · Queensbury, NY · 12804-7619
Is this the product you have?
- BioFlo Midline Catheter and BioFlo
- Maximal Barrier Kits - Product UsageThese introducers are used for the percutaneous introduction of diagnostic or therapeutic devices, such as catheters or pacing leads in the vasculature. Item NumbersCat. No.
H965460151H965460161H965460161-NPH965460171H965460181H965460221H965460231H965460241H965460251H965460261H965460271H965460281H965460291H965464601H965464701H965464701-NPH965464801H965464901
46-01546-01646-016-NP46-01746-01846-02246-02346-02446-02546-02646-02746-02846-02946-46046-47046-48046-490
- Lot codes and dates
- Lots 5478035 5530253 5583183*5585510* 5585511* 5587219* 5552115* 5478044 5530251 5559242 5585515*
54626865468487548719855055445519248552606555302625534809553698955464505567428556950855718685576312558318155010245501025556464754888385478041
5587224* 5519243 5583179* 5585513* 5587221* 5496953 5498175* 5534818* 5589118* 5513035* 5498169 5536984* 5585512* 5589119* 5513036 5474195 5474196 5528626 5496961 5494432 5505549 5546447* 5498170* 5538017* 5474199 5494439 5500300* 5532465*54659695474443548239355049615513039552605655302545534816554402755550835574390558053455831845462685556189454981815566253
5585522* 5585523* 5587229* 5589125* 5555082 5559236 5564648 5578571*76 of 76 codes
546024154805305491810551304055286285538007554852555674305460240546596154659625468486547018854701905474448547803754780385482386548238754823885485167548516854872025487203548883355020905502091550497155055525513042551304355130445519251551925255231945523195552605755260585526059552861555286165530256553025755302585532494553801155380125544036554644355464445557516556188655646465567429557631755805305580531556188755743875559241
5580529* 5583188* 5587222* 5589120*55485215552120556742755743855574386554852055718665548522
5587218*546596454823905523190553481155464485564642556626155763115500294
5589127* 5585519* *All units of these lots are within AngioDynamics control (US and OUS Inventory) and not distributed, therefore, removed from recall notification.54591215462681546848254684835472092547209354805355487199550101855055545526060552861955324595532460553481755380135538014554403555464495557515555923855674335571865557631655805355523191558551854888355504967554852755010165504966550102055662605561891556189254626825480534
- Lots 5478035 5530253 5583183*
- Amount recalled
- 119723 eaches total
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
- Nationwide
Why it was recalled
Certain AngioDynamics PICC Kits contain BD PosiFlush SF Saline Flush Syringes which were recalled by BD Medical on April 16, 2020.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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