B.Braun Accuflo 100ML/H 100ML Elastomeric Infusion Device. AccuFlo devices are intended for patients requiring intraveno
FDA device recall Z-2655-2014 · posted 2014-09-16 · Terminated
Recall details
- Recalling firm
- B. Braun Medical, Inc.
- Reason for recall
- The primary packaging label (inner pouch label) indicates that the package contents are Catalog Item: CT-1000-250, while the secondary packaging label (outer carton label) indicates the contents are CT-1000-100. The actual contents are a CT-1000-100.
- Action taken
- B. Braun Medical Inc. provided the recall notification received from B. Braun Melsungen AG to Progressive Medical Inc. who is the initial importer of the product in the U.S. market. The notification was sent via FedEx and e-mail on/about August 6, 2014 and identified the product, problem, and action to be taken. The notification indicated that if the affected units were further distributed that any distributors are required to forward the letter on to their consignees.
- Root cause
- Labeling Change Control
- Status
- Terminated
- Product code
- MEB
- Quantity affected
- 8,640 units
- Distribution
- Distributed in the state of Missouri.
- Date initiated
- 2014-08-06
- Date posted
- 2014-09-16
- Date terminated
- 2015-01-29
- Location
- Allentown, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ACCUFLOW AND ACCUFLUX ELASTOMERIC INFUSION PUMP (K081905) | Westmed, Inc. | 2008-07-15 |