The finger cots are made out of natural rubber — Class II medical device recall Z-2160-2012
Terminated recall by Afassco Inc, reported 2012-08-15, distributed nationwide. The firm is initiating a field correction because the product(s) were missing the Latex Warning Label. Afassco
| Recall number | Z-2160-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Afassco Inc, Orrville, OH, United States |
| Recall initiated | 2012-02-08 |
| Classified | 2012-08-08 |
| Reported by FDA | 2012-08-15 |
| Terminated | 2014-01-14 |
| Distributed | Nationwide (US) |
| Quantity | 1,956 boxes |
| Reason classes | labeling |
| Model numbers | 5017, 5018 |
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 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."
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2160-2012. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.