Z-2160-2012 Class II Terminated
FDA device recall Z-2160-2012 was initiated by Afassco Inc on February 8, 2012 and is designated Class II. Reason for recall: The firm is initiating a field correction because the product(s) were missing the Latex Warning Label. Afassco Inc. is implementing a voluntary field correction for MULTI-COLORED FINGER COTS because p… The recall status is terminated (terminated January 14, 2014). Affected quantity: 1956 Boxes.
Recall Details
- Product Type
- Devices
- Report Date
- August 15, 2012
- Initiation Date
- February 8, 2012
- Termination Date
- January 14, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1956 Boxes
Product Description
The finger cots are made out of natural rubber. They are disposable products used to cover a fingertip bandage when working with liquids and are intended to keep the fingertip bandage dry. Cots are packed in clear plastic boxes, with 60 cots in a box They are disposable products used to cover a fingertip bandage when working with liquids and are intended to keep the fingertip bandage dry
Reason for Recall
The firm is initiating a field correction because the product(s) were missing the Latex Warning Label. Afassco Inc. is implementing a voluntary field correction for MULTI-COLORED FINGER COTS because product lacked the warning label: "CAUTION: This product contains Natural Rubber Latex which may cause allergic reactions."
Distribution Pattern
Nationwide Distribution including CA, FL. GA. HI, IL, IN, MI, NH, NV, TN, TX, and WV.
Code Information
Recall involves finger cots model #s 5017 and 5018. There is no coding of the boxes or the cots