Radial Artery Catheterization Kit; Model: AK-04220
Reported: April 11, 2018 Initiated: October 26, 2017 #Z-1286-2018
Product Description
Radial Artery Catheterization Kit; Model: AK-04220
Reason for Recall
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.
Details
- Recalling Firm
- Arrow International Inc
- Units Affected
- 6358
- Distribution
- US nationwide distribution, including Puerto Rico.
- Location
- Reading, PA
Frequently Asked Questions
What product was recalled? ▼
Radial Artery Catheterization Kit; Model: AK-04220. Recalled by Arrow International Inc. Units affected: 6358.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 11, 2018. Severity: Moderate. Recall number: Z-1286-2018.
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