Recall Z-2160-2012— Afassco Inc
Class II · Terminated
Class II FDA medical device recall by Afassco Inc, initiated 2012-02-08, terminated 2014-01-14. FDA's recall record names no specific 510(k) clearance for this event. Product: 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: 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.".
- Recalling firm
- Afassco Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-02-08
- Terminated
- 2014-01-14
- Firm location
- Orrville, OH, United States
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."
Data sourced from openFDA. This site is unofficial and independent of the FDA.