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Smiths CADD Medication Cassette Reservoir, With clamp and… recallZ-1215-2007 · Smiths Medical MD, Inc. · initiated Jun 18, 2007

Terminated All recalls posted in August 2007

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

Smith Medical has become aware that an increase in pH may occur with some medications when instilled in the Affected Cassettes. Also, a small number of catheter occlusions have been reported from one customer when these cassettes have been used for delivering Flolan.

FDA root cause category: Other

What the company is doing

All customers who have received the CADD Medication Cassette reservoirs have been sent the Product Recall Notification Letter on June 18, 2007 making them aware of the potential issue. Customers will be required to return the affected devices to Smiths Medical. All returned recall affected product will be quarantined and then destroyed. The consignees are to fill and fax "Attachment 1" form in regard to affected product inventory to Smiths Medical MD.

Recall details

Recall number
Z-1215-2007
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Jun 18, 2007
Posted by the FDA
Aug 30, 2007
Recalling firm
Smiths Medical MD, Inc.
Quantity
113,143
Product code
FPA
FDA submissions
K843772
Distribution
Worldwide, including USA, Canada, Mexico, Sweden, Germany, Japan, Australia, Taiwan, Poland, Jordan, Czech Republic, Denmark, Paraguay, Hong Kong, Singapore, Argentina, Italy, Venezuela, Greece, Norway, Pakistan, Puerto Rico, Thailand, United Arab Emirates, Netherlands Antilles, Malaysia, Panama, Hungary, Saudi Arabia, Portugal, South Africa, Denmark, the Netherlands, France, United Kingdom, Great Britain, Spain, Finland, Guam, Virgin Islands, China, Israel, Austria, and Switzerland.

Product description

Smiths CADD Medication Cassette Reservoir, With clamp and female Luer, Nonvented stopper included, 100 ml PC 4695-24A, REF 21-7002-24, Sterile EO, Made in Mexico Smith Medical MD, Inc. St Paul, MN 55112 USA

Code information (models, lots, serial numbers)

Show the full code information (1k characters)

081X16, 082X16, 085X16, 088X16, 089X16, 090X16, 091X16, 094X16, 095X16, 096X16, 097X16, 104X16, 105X16, 106X16, 107X16, 109X16, 110X16, 112X16, 113X16, 115X16, 119X16, 120X16, 121X16, 122X16, 123X16, 128X16, 129X16, 136X16, 138X16, 142X16, 144X16, 145X16, 149X16, 152X16, 154X16, 155X16, 157X16, 160X16, 161X16, 163X16, 164X16, 167X16, 168X16, 169X16, 170X16, 171X16, 172X16, 173X16, 176X16, 177X16, 179X16, 182X16, 183X16, 186X16, 187X16, 189X16, 190X16, 192X16, 195X16, 196X16, 199X16, 200X16, 203X16, 204X16, 206X16, 207X16, 209X16, 210X16, 211X16, 212X16, 213X16, 214X16, 216X16, 218X16, 220X16, 221X16, 222X16, 223X16, 228X16, 229X16

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.

Other products in the same recall event

The FDA groups related products into one recall event (event 38306).

Sources and updates

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