Recall Z-3071-2017— Smiths Medical ASD Inc.

Name: FDA recall Z-3071-2017
Creator: U.S. Food and Drug Administration
Published: 2017-06-05

Class II · Terminated

Class II FDA medical device recall by Smiths Medical ASD Inc., initiated 2017-06-05, terminated 2020-08-04. It names one FDA 510(k) clearance: K843772. 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.. Reason: 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..

Recalling firm: Smiths Medical ASD Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-06-05
Terminated: 2020-08-04
Firm location: Minneapolis, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K843772 — CADD-1 5100 AMBULATORY INFUSION PUMPDeltec Systems, Inc.·cleared 1984-12-06

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(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.

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.

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