Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and AVI Volumetric Infusion Pump Systems. Model Number RC1201 (Reorder No. 21-0442-25) Primary Checkvalve Administration Set described as 105 inch length/267 cm, 25ml priming volume, 20 drops/ml and 2 Needless Injection site.
This recall has been terminated (originally issued February 2, 2005).
- Company
- Smiths Medical Md, Inc.
- Recall Initiated
- December 3, 2004
- Posted
- February 2, 2005
- Terminated
- June 25, 2006
- Recall Number
- Z-0492-05
- Quantity
- 8,400 units (210 cases) Internationally. Each case contains 40 units.
- Firm Location
- Saint Paul, MN
- Official Source
- View on FDA website ↗
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..
Distribution
worldwide.
Lot / Code Info
FEB04T26 distributed Internationally.
Root Cause
Other
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.