FDAFDA · Food and drugs·Recall number Z-1286-2018
Radial Artery Catheterization Kit; Model: AK-04220
Published April 11, 2018 · Recall initiated: October 26, 2017
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 povidone iodine prep pads included in certain kits and trays do not meet the requirements for a 36-month shelf life and should be labeled with a 24-month shelf life.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Arrow International Inc
- Distributor
- US nationwide distribution, including Puerto Rico.
- Lot
- Lots: 13F16H0429, 13F16M0214, 13F17F0281, 23F16H0161, 23F16J0018; Expiration dates: October 2018 through March 2020
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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