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CADD" Medication Cassette Reservoir, 50mL, REF 21-7001-24… recallZ-1286-2015 · Smiths Medical ASD, Inc. · initiated Feb 2, 2015

Class II Terminated All recalls posted in March 2015

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 ASD, 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 has become aware of an issue with specific lots of 50mL CADD" Medication Cassette Reservoirs (Cassette). Some Cassettes may leak at the sealing area of the pump tube and medication bag. Smiths Medical has received no reports of serious injury or death related to this issue.

FDA root cause category: Under Investigation by firm

What the company is doing

Smiths Medical sent an "Urgent Medical Device Recall" letter dated February 2, 2015, to all affected customers. The letter was addressed to Risk Safety Manger, Biomedical Professionals, Clinicians who oversee the use of CADD pumps, Distributors, and other users of these devices. The letter described the problem and the product involved in the recall. The letter also addressed the "Advice on Action to be Taken by the User", and "Transmission of this Urgent Recall Notice". Customers were requested to complete and return the Confirmation Form by Fax to 1-800-237-8033 or be email to recall.response@smiths-medical. For issues with these products they can contact Smiths Medical's Global Complaint Department at 1-866-216-8806 or [email protected]. For questions on the information provided they can contact Customer Service Department at 1-800-258-5361.

Recall details

Recall number
Z-1286-2015
Recall class
Class II
Status
Terminated
Initiated by the company
Feb 2, 2015
Posted by the FDA
Mar 17, 2015
Recalling firm
Smiths Medical ASD, Inc.
Quantity
48,208 (17,040 US, 31,168 OUS).
Product code
FPA
FDA submissions
K040636, K843772
Distribution
Worldwide Distribution - US (nationwide) Distribution to the states of : AL, AZ, AR, CA, CO, CT, FL, GA, HI, IL IN, IA, MD, MA, MN, MS, MO, NE, NV, NH ,NJ, NM, NY, NC, OH, OR, PA, SD, TN, TX, UT, VA and WA., and to the countries of : Arab Emirates, Austria, Australia, Belgium, Canada, Switzerland, Colombia, Czech Republic, Germany, Denmark, Spain. Finland, France, United Kingdom (GB) Hungary, Indonesia, Ireland, Italy, Netherlands, Portugal, Sweden, Singapore and South Africa.

Product description

CADD" Medication Cassette Reservoir, 50mL, REF 21-7001-24 & 21-7301-24, Sterile EO, Rx only.

Code information (models, lots, serial numbers)

21-7001-24: Lots 14X297 and 14X323 21-7301-24 (Flow Stop): Lot 14X324

Other devices under the same FDA submission

21 devices cleared under K040636, 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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