FDA Medical Device Recalls (openFDA)
Smiths Medical MD, Inc.: Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and AVI Volumetric Infusion Pump Systems. Model Number RC4106 (Reorder No. 21-0402-25) Primary Administration Set described as 105 inch length/267 cm, 25ml priming volume, 20 drops/ml and 1 Needless Injection site.
- Recall number
- Z-0490-05
- Recalling firm
- Smiths Medical MD, Inc.
- Product
- Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and AVI Volumetric Infusion Pump Systems. Model Number RC4106 (Reorder No. 21-0402-25) Primary Administration Set described as 105 inch length/267 cm, 25ml priming volume, 20 drops/ml and 1 Needless Injection site.
- Status
- Terminated
- Initiated
- 2004-12-03
- Posted
- 2005-02-02
- Terminated
- 2006-06-25
- Reason
- 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..
- Root cause
- Other
- Action
- 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.
- Quantity
- 28,640 units (716 cases) Internationally. Each case contains 40 units.
- Distribution
- worldwide.
- Lot, serial or model codes
- FEB04T15, APR04T14 & APR04T22 distributed Internationally.
- 510(k) numbers
- ["K811933","K896161","K991599"]
- PMA numbers
- not on file
- Product code
- FPA
- Firm FEI
- 2183502
- Firm city
- Saint Paul
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28