PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: October 17, 2012 Initiated: September 28, 2012 #Z-0055-2013

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.

Details

Recalling Firm
ICU Medical, Inc.
Units Affected
60
Distribution
Nationwide distribution: Virginia only.
Location
San Clemente, CA

Frequently Asked Questions

What product was recalled?
3 PORT "OFF" MANIFOLD w/WASTE BAG, SYRINGE and DyePod¿, Part Number (Item #) AG8049-NS, Lot # 2528655. K914299. Waste system.. Recalled by ICU Medical, Inc.. Units affected: 60.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on October 17, 2012. Severity: Moderate. Recall number: Z-0055-2013.