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U.S. Department of Health and Human Services

Class 2 Device Recall CADD1 5100 AMBULATORY INFUSION PUMP

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  Class 2 Device Recall CADD1 5100 AMBULATORY INFUSION PUMP see related information
Date Initiated by Firm December 09, 2008
Date Posted April 20, 2009
Recall Status1 Terminated 3 on June 07, 2012
Recall Number Z-0987-2009
Recall Event ID 50829
510(K)Number K843772  
Product Classification Pump, infusion - Product Code FPA
Product 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 Lot Numbers 213X18 and 214X18.
Recalling Firm/
Manufacturer		 Smiths Medical MD, Inc.
1265 Grey Fox Rd
Saint Paul MN 55112-6929
For Additional Information Contact
651-628-7280
Manufacturer Reason
for Recall		 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 Determined
Cause 2		 Process control
Action 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 info.md@smiths-medical.com (in US) or international.customer.service@smiths-medical.com (outside US). Direct questions to the Smiths Medical MD, Inc. Customer Service Department at 1-800-426-2448, Option 1.
Quantity in Commerce 17,868 cassettes (1,489 boxes 12 cassettes/box)
Distribution Worldwide Distribution USA (state of PA) and countries of El Salvador, Australia, France, Finland, Sweden, and Germany.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = FPA and Original Applicant = DELTEC SYSTEMS, INC.
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