Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and AVI Volumetric Infusion Pump
FDA device recall Z-0471-05 · posted 2005-02-02 · Terminated
Recall details
- Recalling firm
- Smiths Medical MD, Inc.
- Reason for recall
- Administration Sets which are used with selected infusion pump systems may have a defect within the fluid path above the upper chamber of the set cassette which does not allow the pump valve to close completely and can allow fluid to leask past and may cause an inaccurate infusion rate..
- Action taken
- Customers were sent a product Safety & Recall notification via email or regular mail begining 12/03/04 through 12/08/04. A Product Recall form requested the customer for feedback as to Quantity Used, Quantity to be Retained and Quantity to be returned . The Customer Recall Notication states that if no Administration Sets from alternative lots are available and the use of the volumetric pump is essential, follow the instructions in the attached Customer Information Bulletin, which describes how to identify a set which does not have the defect. Customers who find product subject to the recall are to contact Smith Medical Customer Service Department to make arrangements to have the affected products returned to Smiths.
- Root cause
- Other
- Status
- Terminated
- Product code
- FPA
- Quantity affected
- 10,800 units (360 cases) within USA. Each contain 30 units.
- Distribution
- worldwide.
- Date initiated
- 2004-12-03
- Date posted
- 2005-02-02
- Date terminated
- 2006-06-25
- Location
- Saint Paul, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CADD ADMINISTRATION SET (K991599) | Sims Deltec, Inc. | 1999-06-15 |
| AVI MODEL 2012, 1.2 MICRON FILTER IV ADMINISTRA. (K896161) | 3M Company | 1990-01-11 |
| GUARDIAN, VOLUMETRIC CONTROL DELIVERY (K811933) | Avi, Inc. | 1981-07-20 |