FDAFDA · Food and drugs·Recall number Z-1269-2013
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.
Published May 15, 2013 · Recall initiated: March 28, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Customers have reported that when separating an individual package from its attached grouping, the adjacent package has opened, compromising its sterile barrier properties.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Baxter Healthcare Corp.
- Distributor
- Worldwide Distribution - USA Nationwide and the countries of Puerto Rico, Brazil, Canada and Columbia.
- Lot
- A) Product Code 2N3371: Lots R12H23076, R12H30097, R12I0707, R12I08059, R12I25046, R12I2607, R12J11052, R12J12068, R12J13058R12K17057, R12L10084, R13A12057
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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