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Deltec branded Administration Sets for use with Deltec 3000… recallZ-0479-05 · Smiths Medical MD, Inc. · initiated Dec 3, 2004

Terminated All recalls posted in February 2005

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Smiths Medical MD, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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..

FDA root cause category: Other

What the company is doing

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.

Recall details

Recall number
Z-0479-05
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Dec 3, 2004
Posted by the FDA
Feb 2, 2005
Recalling firm
Smiths Medical MD, Inc.
Quantity
86,560 units (2,164 cases) within USA. Each case contains 40 units.
Product code
FPA
FDA submissions
K811933, K896161, K991599
Distribution
worldwide.

Product description

Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and AVI Volumetric Infusion Pump Systems. Model Number CC4203 (Reorder No. 21-0339-01) 105 inch length/267 cm, 25ml priming volume, 20 drops/ml, 2 SureSite Prepierced Injection Sites.

Code information (models, lots, serial numbers)

FEB04T11, FEB04T30, MAR04T05 and MAR04T24 distributed within the United States.

Other devices under the same FDA submission

1 device cleared under K811933, K896161, K991599 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 30603).

Sources and updates

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