Z-1831-2016 Class II Terminated
FDA device recall Z-1831-2016 was initiated by Smiths Medical ASD, Inc. on Apr 22, 2016 and is designated Class II. Reason for recall: Smiths Medical became aware that under delivery of medication may occur on CADD Administration Sets with Flow Stop. The recall status is terminated (terminated Dec 13, 2017). Affected quantity: 13,696,830 units.
Recall Details
- Product Type
- Devices
- Report Date
- Jun 8, 2016
- Initiation Date
- Apr 22, 2016
- Termination Date
- Dec 13, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 13,696,830 units
Product Description
CADD Administration Sets with Flow Stop, Product Reorder No: 21-7321-01, 21-7321-24, 21-7322-01, 21-7322-24, 21-7323-24, 21-7324-01, 21-7324-24, 21-7333-24, 21-7336-01, 21-7336-24, 21-7339-01, 21-7339-24, 21-7359-01, 21-7359-24, 21-7383-01, 21-7383-24, 21-7390-01, 21-7390-24, 21-7391-01, 21-7391-24, 21-7394-01, 21-7394-24, 21-7395-24. The CADD Medication Cassette Reservoirs with Flow Stop are a modification to the current CADD Medication Cassette Reservoirs. The reservoirs will incorporate a set-based free flow protection component (i.e. Flow Stop) that is designed to occlude the tube if the reservoirs are accidentally placed onto the pump incorrectly or become detached from the pump. The Flow Stop will be located on the reservoir housing, which is attached to the pump. The reservoir will be provided to the user in an open state. Before the reservoir can be attached to the pump, the blue "CLIP" must be removed to activate the Flow Stop. However, after attaching the reservoir to the pump, the user can still remove the reservoir from the pump and prime it by holding the Flow Stop in the open position.
Reason for Recall
Smiths Medical became aware that under delivery of medication may occur on CADD Administration Sets with Flow Stop.
Distribution Pattern
US: ALL STATES IN CONTINENTAL USA INCLUDING DC AND PR EXCEPT DE. OUS: UNITED ARAB EMIRATES, AUSTRIA BELGIUM, CANADA, CHINA, GERMANY, DENMARK, SPAIN, FINLAND, FRANCE, GREAT BRITAIN, HONG KONG, IRELAND, INDIA, ITALY, JAPAN, LUXEMBOURG, MAURITIUS, NEW CALEDONIA, NEW ZEALAND, PANAMA, PORTUGAL, SAUDI ARABIA, SWEDEN, SINGAPORE, TAIWAN, VIET NAAM, SOUTH AFRICA.
Code Information
Devices with an expiration date on or before March 2021
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1831-2016
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026