FDAFDA · Food and drugs·Recall number Z-0143-2014
Dual Luer Lock Cap The device is intended for use as a cap for male or female Luer ports on medical devices such as manifolds, stopcocks or sets.
Published November 13, 2013 · Recall initiated: September 10, 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
The firm is recalling lots 10043 and 10044 due to loose particulate matter found in the packaging. Particulate matter entering the fluid path from the Luer lock caps may result in embolic events.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Baxter Healthcare Corp.
- Distributor
- Worldwide Distribution - USA (nationwide) and the country of Canada.
- Lot
- 10043, 10044
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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