Recall record at a glance
| Official record | Z-2398-2020 |
|---|---|
| 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 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
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.
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