Recall Z-0055-2013— ICU Medical, Inc.

Name: FDA recall Z-0055-2013
Creator: U.S. Food and Drug Administration
Published: 2012-09-28

Class II · Terminated

Class II FDA medical device recall by ICU Medical, Inc., initiated 2012-09-28, terminated 2013-02-19. It names one FDA 510(k) clearance: K914299. Product: 3 PORT "OFF" MANIFOLD w/WASTE BAG, SYRINGE and DyePod¿, Part Number (Item #) AG8049-NS, Lot # 2528655. K914299. Waste system.. Reason: ICU Medical, Inc. has identified a potential comingling of components where a 60 drop micro drip chamber may have been included on a 20 drop macro drip set..

Recalling firm: ICU Medical, Inc.
Classification: Class II
Status: Terminated
Initiated: 2012-09-28
Terminated: 2013-02-19
Firm location: San Clemente, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K914299 — CARDIAC CATHERIZATION KITAbbott Laboratories·cleared 1992-06-03

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

3 PORT "OFF" MANIFOLD w/WASTE BAG, SYRINGE and DyePod¿, Part Number (Item #) AG8049-NS, Lot # 2528655. K914299. Waste system.

Reason for recall

ICU Medical, Inc. has identified a potential comingling of components where a 60 drop micro drip chamber may have been included on a 20 drop macro drip set.

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