The Alcon Custom Pak. The Alcon Customer Pak is an assemblage of single-use medical devices and accessories designed by medical professionals for specific ophthalmic surgical procedures. Some Paks contain the Devon Light Glove.
Reported: June 10, 2015 Initiated: April 28, 2015 #Z-1702-2015
Product Description
The Alcon Custom Pak. The Alcon Customer Pak is an assemblage of single-use medical devices and accessories designed by medical professionals for specific ophthalmic surgical procedures. Some Paks contain the Devon Light Glove.
Reason for Recall
The supplier of the Devon Light Glove, a component of the Alcon Custom PAK, recalled the gloves due to the potential for splits and holes on the glove. Should the user be unaware that the Light Glove is torn/split, surgical site infections are possible.
Details
- Recalling Firm
- Alcon Research, Ltd.
- Units Affected
- 219,680 units
- Distribution
- Worldwide Distribution - US Nationwide and the countries of Australia and Canada.
- Location
- Fort Worth, TX
Frequently Asked Questions
What product was recalled? ▼
The Alcon Custom Pak. The Alcon Customer Pak is an assemblage of single-use medical devices and accessories designed by medical professionals for specific ophthalmic surgical procedures. Some Paks contain the Devon Light Glove.. Recalled by Alcon Research, Ltd.. Units affected: 219,680 units.
Why was this product recalled? ▼
The supplier of the Devon Light Glove, a component of the Alcon Custom PAK, recalled the gloves due to the potential for splits and holes on the glove. Should the user be unaware that the Light Glove is torn/split, surgical site infections are possible.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 10, 2015. Severity: Moderate. Recall number: Z-1702-2015.
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