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CADD Medication Cassette Reservoir 100 ml with Clamp and… recallZ-0987-2009 · Smiths Medical MD, Inc. · initiated Dec 9, 2008

Terminated All recalls posted in April 2009

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

Smiths Medical noticed an increased trend in leakage associated with 100 ml CADD Medication Cassette Reservoirs Reorder Number 21-7002-24 Lot Numbers 213X18 and 214X18. If a leak occurs in a CADD medication Cassette Reservoir, it may allow spillage of medication, contamination of the fluid path, and/or air to enter the Reservoir. Smiths Medical has not received any report of patient injuries due

FDA root cause category: Process control

What the company is doing

An "Urgent Medical Device Recall" letter was sent via electronic mail to consignees on December 8, 2008. The letter was addressed to Distributors, Clinicians and other Customers. The letter described the problem and affected product and listed the "Advise on Action to be Taken by the User". Smiths Medical MD, Inc. requested the user to complete and return the "Urgent Medical Device Recall Confirmation Fax Return Form" and fax to the firm at 1-651-628-7485 or e-mail to [email protected] (in US) or [email protected] (outside US). Direct questions to the Smiths Medical MD, Inc. Customer Service Department at 1-800-426-2448, Option 1.

Recall details

Recall number
Z-0987-2009
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Dec 9, 2008
Posted by the FDA
Apr 20, 2009
Recalling firm
Smiths Medical MD, Inc.
Quantity
17,868 cassettes (1,489 boxes 12 cassettes/box)
Product code
FPA
FDA submissions
K843772
Distribution
Worldwide Distribution USA (state of PA) and countries of El Salvador, Australia, France, Finland, Sweden, and Germany.

Product description

CADD Medication Cassette Reservoir 100 ml with Clamp and Female Leur, Nonvented stopper included REF 21-7002-24, Sterile EO. CADD Medication Cassette Reservoirs are intended for use with the CADD Ambulatory Infusion Pumps used for delivering drug therapy and anesthesia to patients. The pumps can be used by home care patients and in a healthcare facility.

Code information (models, lots, serial numbers)

Lot Numbers 213X18 and 214X18.

Other devices under the same FDA submission

3 devices cleared under K843772 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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