Z-0055-2013Class II

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

Name: Z-0055-2013 3 PORT "OFF" MANIFOLD w/WASTE BAG, SYRINGE and DyePod, Part Number (Item #) AG8049-NS, Lot # 2528655...
Creator: ICU Medical, Inc.
Published: 2012-09-28
License: https://open.fda.gov/license/

Abbott Medical / initiated 2012-09-28 / Terminated

FDA source

ICU Medical, Inc. began a recall of 3 PORT "OFF" MANIFOLD w/WASTE BAG, SYRINGE and DyePod, Part Number (Item #) AG8049-NS, Lot # 2528655. K914299. Waste system on 2012-09-28. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0055-2013
Classification: Class II
Status: Terminated
Initiated: 2012-09-28
Posted: 2012-10-11
Terminated: 2013-02-19
Recalling firm: Abbott Medical
Product: 3 PORT "OFF" MANIFOLD w/WASTE BAG, SYRINGE and DyePod, Part Number (Item #) AG8049-NS, Lot # 2528655. K914299. Waste system.
Product code: DQO Catheter, Intravascular, Diagnostic
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.
FDA root cause: Mixed-up of materials/components
Action: ICU Medical sent an "URGENT:MEDICAL DEVICE RECALL" letter dated September 28, 2012 to its customer. The letter identified the product, problem, and actions to be taken by the customer. The customer has been instructed to inspect their inventory for the specific lot numbers, examine for the presence of a metal cannula, and certify destruction of any affected devices. The customer letter included a Verification Form to be completed and returned. Contact ICU Customer Service Monday through Friday between the hours of 8:30 AM and 4:00 PM Pacific time: 866-829-9025 and select option 8, or e-mail the following address: [email protected]" for questions regarding this notice.
Quantity in commerce: 60
Distribution: Nationwide distribution: Virginia only.
Product codes and lots: Part Number (Item #) AG8049-NS, Lot # 2528655.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0055-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0055-2013	Class II	Terminated	Voluntary: Firm initiated	2012-10-17	2012-10-11

Product code DQO

K914299Class IICardiac Catherization KitAbbott Laboratories / cleared 1992-06-03

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)