FDA Medical Device Recalls (openFDA)
Afassco Inc: 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
- Recall number
- Z-2160-2012
- Recalling firm
- Afassco Inc
- 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
- Status
- Terminated
- Initiated
- 2012-02-08
- Posted
- 2012-08-08
- Terminated
- 2014-01-14
- 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."
- Root cause
- 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
- 1956 Boxes
- Distribution
- Nationwide Distribution including CA, FL. GA. HI, IL, IN, MI, NH, NV, TN, TX, and WV.
- Lot, serial or model codes
- Recall involves finger cots model #s 5017 and 5018. There is no coding of the boxes or the cots
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FQM
- Firm FEI
- 3017657529
- Firm city
- Orrville
- Firm state
- OH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28