Recall record at a glance
| Official record | Z-2397-2020 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Angiodynamics, Inc. |
| Report date | Jun 24, 2020 |
| Recall initiation date | May 4, 2020 |
| Quantity | 119723 eaches total |
| Location | Queensbury, NY, United States |
Official product description
BioFlo PICC and Xcela PICC Convenience Kits - Product Usage: are indicated 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 and nutrients; the sampling of blood; and for power injection of contrast media. Item Numbers H96560M01162101 H96560M0116291 H96560M0133531 H96560M0134211 H96560M0198811 H96560M0224741 H96560M0224751 H96560M0335621 H96560M0367041 H96560M0367051 H96560M0367061 H96560M05019111 H96560M0501981 H96560M1201961 H96560M1201971 H96560M12202101 H96560M12202111 H96560M12202121 H96560M1303151 H96560M1303171 H96560M1303191 H96560M13184101 H96560M13184111 H96560M1318491 H96560M1401411 H96560M1401421 H96560M1401431 H96560M1401441 H96560M1406061 H96560M1406071 H96560M1633931 H96560M1803441 H96560M1803451 H96560M18157111 H96560M18157121 H96560M1841151 H96560M1841161 H96560M1841171 H96560M1907131 H96560M1907141 H96560M2204441 H96560M2208511 H96560M2208521 H96560M2322421 H96560M2500961 H96560M2500971 H96560M610115911 H96560M610901011 H96560M611025121 H96560M611025131 H96560M611052821 H96560M611056021 H96560M611056031 H96560M611095821 H96560M611095831 H965PKM030667S1 H965PKM120451S1 H965PKM1220226S1 H965PKM1300011S1 H965PKM1303119S1 H965PKM131935S1 H965PKM150124S1 H965PKM150125S1 H965PKM150127S1 H965PKM220851S1 H965PKM220854S1 H965PKM3092662S1 H965PKM61040701S1 H965PKM61066141S1 H965PKM61095321S1 H965PKM61095324S1 Cat. No. 60M0116210 60M011629 60M013353 60M013421 60M019881 60M022474 60M022475 60M033562 60M036704 60M036705 60M036706 60M0501911 60M050198 60M120196 60M120197 60M1220210 60M1220211 60M1220212 60M130315 60M130317 60M130319 60M1318410 60M1318411 60M131849 60M140141 60M140142 60M140143 60M140144 60M140606 60M140607 60M163393 60M180344 60M180345 60M1815711 60M1815712 60M184115 60M184116 60M184117 60M190713 60M190714 60M220444 60M220851 60M220852 60M232242 60M250096 60M250097 60M61011591 60M61090101 60M61102512 60M61102513 60M61105282 60M61105602 60M61105603 60M61109582 60M61109583 PKM030667S PKM120451S PKM1220226S PKM1300011S PKM1303119S PKM131935S PKM150124S PKM150125S PKM150127S PKM220851S PKM220854S PKM3092662S PKM61040701S PKM61066141S PKM61095321S PKM61095324S
Why the product was recalled
Certain AngioDynamics PICC Kits contain BD PosiFlush SF Saline Flush Syringes which were recalled by BD Medical on April 16, 2020.
Distribution information
US Nationwide distribution.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
FDA source limitation: openFDA enforcement reports are a reference dataset, not a live public-alert or recall-lifecycle service. FDA notes that enforcement-report status may not be updated after classification. Confirm current actions with the FDA, recalling firm or appropriate healthcare professional when relevant.