High FDA (Devices)·Z-1270-2013·Announced 2013-05-15

Baxter Recalls Non-DEHP Catheter Extension Sets Due to Sterile Barrier Compromise

Baxter Healthcare is recalling specific lots of Non-DEHP Catheter Extension Set Kits because separating packages can compromise the sterile barrier of adjacent units.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a compromised sterile barrier, which is a significant risk of harm (infection) for a medical device, but no injuries or illnesses have been reported, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Baxter Healthcare Corp. is recalling specific lots of Non-DEHP Catheter Extension Set Kits and V-LINK Luer Activated Device kits. The affected products are single-use medical devices intended for the administration and withdrawal of fluids via vascular access devices. The recall includes product codes 2N8220, 2N8221, 2N8222, 2N8223, 6N8220, and 6N8222, with a total of 75,250 units distributed worldwide, including the United States, Puerto Rico, Brazil, Canada, and Colombia.

The recall was initiated after customers reported that when separating an individual package from its attached grouping, the adjacent package opened, compromising its sterile barrier properties. This defect poses a risk of contamination to the sterile medical device. The FDA has classified this as a Class II recall, indicating a reasonable probability that use of the product could cause temporary or medically reversible health consequences.

Healthcare facilities and distributors should stop using the affected lots immediately. Users should check their inventory for the specific product codes and lot numbers listed in the recall notice. If the product is found, it should be quarantined and returned to Baxter Healthcare Corp. according to their instructions. No illnesses or injuries have been reported in connection with this recall.

The recalled product

Product: A) Product Code 2N8220: Non-DEHP Catheter Extension Set Kit, Single use only, includes: 1) 7.7", Vol. 1.10 mL, Luer Activated Valve for IV Access, Male Luer Lock Adapter, 2) Medium Catheter Stabilization Device, and 3) Foam Tape Strips; B) Product Code 2N8221: Non-DEHP Cathe
Manufacturer: Baxter Healthcare Corp.
Category: Medical Device — IV Catheter Extension Sets
Hazard: sterile-barrier-compromise
infection-risk

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (15)

A) Product Code 2N8220: Lots R12J05070
B) Product Code 2N8221: Lots R12J20046
R12J22042
C) Product Code 2N8222: Lots R12L07031
D) Product Code 2N8223: Lots R12L06074
R12K02083
E) Product Code 6N8220: Lots R12I01054
R12H25048
R12H27192
R12J04057
R12J22109
R12L07049
R12L08088
F) Product Code 6N8222: Lots R12J15046
R12J23115

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 4 recalled by Baxter Healthcare Corp. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

Same manufacturer · Baxter Healthcare Corp.

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