CLASS II Device recall · Reported 17 Oct 2012 · FDA Enforcement Report

3 Port "Off" Manifold w/Waste, Syringe and DyePod¿ recalled

ICU Medical is recalling 3 Port "Off" Manifold w/Waste, Syringe and DyePod¿, distributed nationwide in the US. The recall was initiated on 28 Sep 2012 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesPart Number (Item #) AG8049-NS, Lot # 2528655.

Quantity recalled60

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0055-2013
FDA event ID: 63362
Recalling firm: ICU Medical, San Clemente, CA
Classification: Class II
Status: Terminated
Recall initiated: 28 Sep 2012
FDA classified: 11 Oct 2012
Reported: 17 Oct 2012
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Syringes & Needles

Timeline

28 Sep 2012	Recall initiated by company
11 Oct 2012	Classified by FDA	+13 days
17 Oct 2012	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

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

Where it was distributed

Nationwide distribution: Virginia only.

Nationwide Virginia

Questions about this recall

Why was it 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 lots are affected?

Part Number (Item #) AG8049-NS, Lot # 2528655.

Where was it sold?

Nationwide distribution: Virginia only.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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