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Class 2 Device Recall CADD(R) Medication Cassette with clamp and female Luer |
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Date Initiated by Firm |
June 05, 2017 |
Create Date |
August 25, 2017 |
Recall Status1 |
Terminated 3 on August 04, 2020 |
Recall Number |
Z-3071-2017 |
Recall Event ID |
77555 |
510(K)Number |
K843772
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Product Classification |
Pump, infusion - Product Code FRN
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Product |
CADD(R) Medication Cassette Reservoir with clamp and female Luer. Non vented stopper included, REF 21-7002-24, Rx only, STERILE EO, Manufacturer Smiths Medical ASD, Inc. |
Code Information |
lot number 16X659 |
Recalling Firm/ Manufacturer |
Smiths Medical ASD Inc. 6000 Nathan Ln N Minneapolis MN 55442-1690
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Manufacturer Reason for Recall |
The medication cassette reservoir, part number
21-7002-24, with lot number 16X659, may have been manufactured with the incorrect pressure plate and the tubing used on the cassette may have been routed
incorrectly.
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FDA Determined Cause 2 |
Process change control |
Action |
Consignees (may include distributors and hospitals) in Japan were notified the week of June 5, 2017. Recall letters were delivered by Smiths Medical, Japan sales representatives during the week of 06/19/2017.
The consignees were directed to return any affected devices in their possession and receive replacements. Their Smiths Medical sales representative will collect the affected product and replacement product will be sent to them. |
Quantity in Commerce |
17280 units |
Distribution |
Japan, China, US |
Total Product Life Cycle |
TPLC Device Report
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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.
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510(K) Database |
510(K)s with Product Code = FRN and Original Applicant = DELTEC SYSTEMS, INC.
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