AngioVac Circuit Pack (Tandem Packs), REF/Catalog No. 25-187, UPN H965251870, STERILE, Rx Only, Single Use Only -- The A
FDA device recall Z-1702-2016 · posted 2016-05-20 · Terminated
Recall details
- Recalling firm
- Angiodynamics Inc. (Navilyst Medical Inc.)
- Reason for recall
- Maquet Cardiopulmonary, the manufacturer of the RotaFlow Centrifugal Pump, determined that the products may possess levels of endotoxin that exceed regulatory limits. AngioDynamics confirmed that the affected RotaFlow Centrifugal Pumps were included in packaged AngioVac Circuit Packs.
- Action taken
- On 3/21/2016, AngioDynamics sent recall notification packages (dated 3/21/2016) to the consignees via Federal Express. Consignees are instructed to follow the instructions provided on the Maquet Cardiopulmonary recall letter (dated 2/23/2016) and return the Reply Verification Tracking Form, provided in the recall notification.
- Root cause
- Environmental control
- Status
- Terminated
- Product code
- DWE
- Quantity affected
- Domestic: 377 kits
- Distribution
- Nationwide Distribution.
- Date initiated
- 2016-03-21
- Date posted
- 2016-05-20
- Date terminated
- 2017-09-18
- Location
- Glens Falls, NY
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AngioVac Circuit (K142607) | Angiodynamics | 2014-12-11 |