Recall Z-2759-2017— Smiths Medical ASD Inc.

Name: FDA recall Z-2759-2017
Creator: U.S. Food and Drug Administration
Published: 2016-12-09

Class II · Terminated

Class II FDA medical device recall by Smiths Medical ASD Inc., initiated 2016-12-09, terminated 2017-12-14. It names one FDA 510(k) clearance: K933390. Product: Smiths Medical CADD Blue-Striped IV Administration Set, REF 21-7036-01, Sterilized using ethylene oxide.. Reason: The label of the CADD Blue-Striped Administrative Set is missing the expiration date, which is considered a regulatory compliance issue for Canada..

Recalling firm: Smiths Medical ASD Inc.
Classification: Class II
Status: Terminated
Initiated: 2016-12-09
Terminated: 2017-12-14
Firm location: Minneapolis, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K933390 — REMOTE RESERVOIR ADAPTER(TM) CASSETTE WITH BAGPharmacia Deltec, Inc.·cleared 1994-02-09

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

Smiths Medical CADD Blue-Striped IV Administration Set, REF 21-7036-01, Sterilized using ethylene oxide.

Reason for recall

The label of the CADD Blue-Striped Administrative Set is missing the expiration date, which is considered a regulatory compliance issue for Canada.

Data sourced from openFDA. This site is unofficial and independent of the FDA.