CLASS II Device recall · Reported 15 May 2013 · FDA Enforcement Report

A) Product recalled by Baxter Healthcare

Baxter Healthcare is recalling A) Product, distributed nationwide in the US. The recall was initiated on 28 Mar 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesA) Product Code 2N3371: Lots R12H23076, R12H30097, R12I0707, R12I08059, R12I25046, R12I2607, R12J11052, R12J12068, R12J13058R12K17057, R12L10084, R13A12057

Quantity recalledA) Product Code 2N3371: 228,200 units

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-1269-2013
FDA event ID: 64696
Recalling firm: Baxter Healthcare, Deerfield, IL
Classification: Class II
Status: Terminated
Recall initiated: 28 Mar 2013
FDA classified: 7 May 2013
Reported: 15 May 2013
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Heart & Vascular Devices

Timeline

28 Mar 2013	Recall initiated by company
7 May 2013	Classified by FDA	+40 days
15 May 2013	Published in enforcement report	+8 days

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

Reason for recall

Customers have reported that when separating an individual package from its attached grouping, the adjacent package has opened, compromising its sterile barrier properties.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

A) Product Code 2N3371: Non-DEHP Y-Type Catheter Extension Set, 5.7", Vol. 0.8 mL, 2 Injection Sites, Male Luer Lock Adapter, Single use only Product Usage: This device is indicated for use in blood sampling and the administration of solutions. The InterLink Injection Site feature is intended to eliminate accidental needle sticks when used in conjunction with an InterLink Cannula as part of an I.V. needless access system.

Where it was distributed

Worldwide Distribution - USA Nationwide and the countries of Puerto Rico, Brazil, Canada and Columbia.

Nationwide Puerto Rico

Questions about this recall

Is A) Product recalled?

Yes. Baxter Healthcare recalled A) Product on 28 Mar 2013. The recall is Class II and its status is Terminated. Recall number Z-1269-2013.

Why was it recalled?

Customers have reported that when separating an individual package from its attached grouping, the adjacent package has opened, compromising its sterile barrier properties.

Which lots are affected?

A) Product Code 2N3371: Lots R12H23076, R12H30097, R12I0707, R12I08059, R12I25046, R12I2607, R12J11052, R12J12068, R12J13058R12K17057, R12L10084, R13A12057

Where was it sold?

Worldwide Distribution - USA Nationwide and the countries of Puerto Rico, Brazil, Canada and Columbia.

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 21 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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