FDA Device recall Z-2398-2020
BioFlo PICC and Xcela PICC Maximal Barrier Nursing Kits - Product Usage: are indicated for short or long-term peripheral access to the cent…
- FDA Device
- Class II
- terminated
- Published 2020-06-24
On 2020-06-24 the FDA classified a Class II recall of BioFlo PICC and Xcela PICC Maximal Barrier Nursing Kits - Product Usage: are indicated for short or long-term peripheral access to the cent… by Angiodynamics, citing certain AngioDynamics PICC Kits contain BD PosiFlush SF Saline Flush Syringes which were recalled by BD Medical on April 16, 2020.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2398-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-05-04 |
| Published | 2020-06-24 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Angiodynamics |
| Distribution | US |
Product
BioFlo PICC and Xcela PICC Maximal Barrier Nursing 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 H965750011 H965750031 H965750121 H965750131 H965750141 H965750151 H965750161 H965750171 H965750181 H965750191 H965750211 H965750221 H965750231 H965750241 H965750315 H965750315-NP H965750325 H965750335 H965750335-NP H965750345 H965750355 H965750355-NP H965750365 H965750375 H965750385 H965750415 H965750425 H965750441 H965750451 H965750471 H965750481 H965750491 H965750501 H965750521 H965750531 H965750541 H965750551 H965750561 H965750571 H965750581 H965750591 H965750601 H965750611 H965750621 H965750631 H965750651 H965750661 H965750671 H965750681 H965750691 H965750701 Cat. No. 75-001 75-003 75-012 75-013 75-014 75-015 75-016 75-017 75-018 75-019 75-021 75-022 75-023 75-024 75-031 75-032 75-033 75-034 75-035 75-036 75-037 75-038 75-041 75-042 75-044 75-045 75-047 75-048 75-049 75-050 75-052 75-053 75-054 75-055 75-056 75-057 75-058 75-059 75-060 75-061 75-062 75-063 75-065 75-066 75-067 75-068 75-069 75-070
Reason
Certain AngioDynamics PICC Kits contain BD PosiFlush SF Saline Flush Syringes which were recalled by BD Medical on April 16, 2020.
Identifiers
| code_info | Lots 5532456 5546446 5468484 5574393* 5578573* 5468479 5480529 5488836 5491816 5505550 5523189 5528614 5534…Lots 5532456 5546446 5468484 5574393* 5578573* 5468479 5480529 5488836 5491816 5505550 5523189 5528614 5534810 5555087 5465967 5505541 5526062 5532463 5538009 5544033 5557511 5566262 5576313 5585520 5478042 5498174 5589122* 5491811 5571860* 5465968 5485166 5513045 5530259 5534812 5538008 5557514 5567431 5504965 5580537 5472096 5587227* 5522942 5462677 5478036 5487208 5498183 5519246 5528617 5530255 5536985 5544026 5567424 5578574 5585516 5557513 5564638 5459118 5460231 5468489 5474445 5482389 5487204 5513038 5523192 5528625 5532462 5534813 5536986 5544034 5552122 5559237 5567425 5569506 5580533 5498179 5574395 5491813 5465970 5561893 5504968 5589123* 5462684 5482396 5491812 5498177 5513041 5526061 5534814 5544028 5552119 5559239 5574394 5587217 5462678 5462679 5474447 5480531 5480532 5487206 5505542 5513049 5523196 5532461 5534815 5544030 5546451 5574392 5555084 5569505 5585517 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2398-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.