CLASS II Device recall · Reported 7 Sep 2016 · FDA Enforcement Report
Baxter Non-DEHP Micro-Volume Extension Set recalled by Baxter Healthcare
Baxter Healthcare is recalling Baxter Non-DEHP Micro-Volume Extension Set, Male Luer Lock Adapter, 36, Volume, distributed nationwide in the US. The recall was initiated on 14 Dec 2012 and the FDA has classified it as Class II.
Check your package
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-2687-2016
- FDA event ID
- 63898
- Recalling firm
- Baxter Healthcare, Round Lake, IL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 14 Dec 2012
- FDA classified
- 29 Aug 2016
- Reported
- 7 Sep 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Heart & Vascular Devices
Timeline
| 14 Dec 2012 | Recall initiated by company | |
| 29 Aug 2016 | Classified by FDA | +1354 days |
| 7 Sep 2016 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Some of the individual extension set packages were improperly sealed, compromising the sterility of the product.
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
Baxter Non-DEHP Micro-Volume Extension Set, Male Luer Lock Adapter, 36 (91 cm), Volume 0.32 mL; an Rx sterile, single use nonpyrogenic fluid pathway; 50 sets per case; For the administration of drugs and solutions to a patient's vascular system through a vascular access device.
Where it was distributed
Worldwide Distribution - US including FL, GA, IL, KS, KY, MI, MO, NC, ND, OH, PA, SC, TN, TX, WV, Puerto Rico and Internationally to Canada.
Nationwide FloridaGeorgiaIllinoisKansasKentuckyMichiganMissouriNorth CarolinaNorth DakotaOhioPennsylvaniaPuerto RicoSouth CarolinaTennesseeTexasWest Virginia
Questions about this recall
Is Baxter Non-DEHP Micro-Volume Extension Set, Male Luer Lock Adapter, 36, Volume recalled?
Yes. Baxter Healthcare recalled Baxter Non-DEHP Micro-Volume Extension Set, Male Luer Lock Adapter, 36, Volume on 14 Dec 2012. The recall is Class II and its status is Terminated. Recall number Z-2687-2016.
Why was it recalled?
Some of the individual extension set packages were improperly sealed, compromising the sterility of the product.
Which lots are affected?
product code 2N3345, lot number UR12E03108
Where was it sold?
Worldwide Distribution - US including FL, GA, IL, KS, KY, MI, MO, NC, ND, OH, PA, SC, TN, TX, WV, Puerto Rico and Internationally to Canada.
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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