Recall Z-1286-2015— Smiths Medical ASD, Inc.
Class II · Terminated
Class II FDA medical device recall by Smiths Medical ASD, Inc., initiated 2015-02-02, terminated 2016-03-18. It names 2 FDA 510(k) clearances: K040636, K843772. Product: CADD" Medication Cassette Reservoir, 50mL, REF 21-7001-24 & 21-7301-24, Sterile EO, Rx only.. Reason: 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..
- Recalling firm
- Smiths Medical ASD, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-02-02
- Terminated
- 2016-03-18
- Firm location
- Saint Paul, MN, United States
510(k) clearances named in this recall
2 on FDA's record- K040636 — CADD ADMINISTRATION SET WITH FLOW STOP, MEDICATION CASSETTE RESERVOIR WITH FLOW STOP AND EXTENSION SET
- K843772 — CADD-1 5100 AMBULATORY INFUSION PUMP
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
CADD" Medication Cassette Reservoir, 50mL, REF 21-7001-24 & 21-7301-24, Sterile EO, Rx only.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.