Reported Jun 24, 2020 · Terminated
BioFlo Midline Convenience Kits - Product Usage: These introducers are used for the percutaneous introduction of…
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
- Convenience 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.
H96560M0125711H96560M0133541H96560M0354721H96560M0367081H96560M05019121H96560M05019131H96560M1220291H96560M1303161H96560M1303181H96560M1318211H96560M1408911H96560M1429481H96560M1803431H96560M18157131H96560M2208531H96560M2208541H96560M2500981H96560M611025111H96560M611052811H96560M611056011H96560M611095811H965PKM1387818S1H965PKM1404211S1H965PKM1635214S1H965PKM220533S1H965PKM220853S1H965PKM220855S1H965PKM61095322S1H965PKM61102511S1
60M01257160M01335460M03547260M03670860M050191260M050191360M12202960M13031660M13031860M13182160M14089160M14294860M18034360M181571360M22085360M22085460M25009860M6110251160M6110528160M6110560160M61109581PKM1387818SPKM1404211SPKM1635214SPKM220533SPKM220853SPKM220855SPKM61095322SPKM61102511S
- Lot codes and dates
- Lots 5513075 5543988 5569542 5580342*5580584*
548881955130695555125556954854544445469653550301455057225463227546851254805025502087551922655302665546401555213755695505488815
5576297* 5580586* 5588914*5474463551306755718885462690547210655020775513079552868355464155557545556635654888255530192
5588900*5468514547804654918395496906550024355369505574449558725855646745470097547083454779835482399553240255369565567559557190055785535543994
5571896* 5580582* 5587276*557411654773565479479549292654975615542304555098155045225542305558402455840395470195547210454779385505005552316955286765534740553998054982455564682
5587263*546849254701915472098548881155050035532394553696255575555567546
5585529* 5587815* 5560886 5513081 5539976 5589180*550185155018535470197548050855002495504999552317355464175566339553018555192165523155552600655369585559207
*All units of these lots are within AngioDynamics control (US and OUS Inventory) and not distributed, therefore, removed from recall notification.5557537554842555050705481670548648955369365504526550452754773735586746
- Lots 5513075 5543988 5569542 5580342*
- 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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