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.
Recall
- Recall Number
- Z-1831-2016
- Event Number
- 73923
- Firm
- Smiths Medical ASD, Inc.
- FEI Number
- 2183502
- Product Code
- FPA
- Status
- Terminated
- Root Cause
- Nonconforming Material/Component
- Initiated
- April 22, 2016
- Terminated
- December 13, 2017
- Address
- 1265 Grey Fox Rd, Saint Paul, MN, 55112-6929
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.
Smiths Medical became aware that under delivery of medication may occur on CADD Administration Sets with Flow Stop.
Smiths Medical sent an "Urgent Medical Device Field Correction Action" letter dated April 20, 2016. The letter was addressed to "Clinicians who oversee the use of the CADD Administration Sets with Flow Stop and Distributors thereof". The letter described the Affected devices, Reason for Field Correction Action, Risk to Health, and Instructions to Customers (Distributors and Clinicians). Requested consignees to complete and return the "Field Corrective Action Confirmation Form". For questions regarding this notification, contact Smiths Medical Customer Service Department at 1-866-831-8399.
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13,696,830 units