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U.S. Department of Health and Human Services

Class 2 Device Recall Afassco Finger Cots

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  Class 2 Device Recall Afassco Finger Cots see related information
Date Initiated by Firm February 08, 2012
Date Posted August 08, 2012
Recall Status1 Terminated 3 on January 14, 2014
Recall Number Z-2160-2012
Recall Event ID 62645
Product Classification Bandage, elastic - Product Code FQM
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
Code Information Recall involves finger cots model #s 5017 and 5018.  There is no coding of the boxes or the cots
Recalling Firm/
Manufacturer		 Afassco Inc
228 W Chestnut St
Orrville OH 44667-1904
For Additional Information Contact Angie Gibson
775-783-3555
Manufacturer 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."
FDA Determined
Cause 2		 Packaging process control
Action Afassco sent a Field Correction Notice to all affected customers. The Notice identified the product, the problem, and the action to be taken by the customer. Labels have been included with the notices that the firm will be sending to their distributors. The distributors were asked to examine their inventory and affix the caution label to the boxes of affected product. If additional warning labels are needed, they may contact Afassco (800-441-6774) for additional labels. If they have further distributed these products, they should notify consignees of the field correction. Their notification to their customers may be enhanced by including a copy of the notice sent to them. The recall should be carried out to the user level. For any questions customers may call 1-880-441-6774. For questions regarding this recall call 775-783-3555.
Quantity in Commerce 1956 Boxes
Distribution Nationwide Distribution including CA, FL. GA. HI, IL, IN, MI, NH, NV, TN, TX, and WV.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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