Z-2160-2012Class II

The finger cots are made out of natural rubber. They are disposable products used to cover a fingertip...

Name: Z-2160-2012 The finger cots are made out of natural rubber. They are disposable products used to cover a fingertip...
Creator: Afassco Inc
Published: 2012-02-08
License: https://open.fda.gov/license/

Afassco Inc / initiated 2012-02-08 / Terminated / root cause: packaging

FDA source

Afassco Inc began a recall of 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... on 2012-02-08. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2160-2012
Classification: Class II
Status: Terminated
Initiated: 2012-02-08
Posted: 2012-08-08
Terminated: 2014-01-14
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
Product code: FQM Bandage, Elastic
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."
Root cause tag: packaging
FDA 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 in commerce: 1956 Boxes
Distribution: Nationwide Distribution including CA, FL. GA. HI, IL, IN, MI, NH, NV, TN, TX, and WV.
Product codes and lots: Recall involves finger cots model #s 5017 and 5018. There is no coding of the boxes or the cots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2160-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2160-2012	Class II	Terminated	Voluntary: Firm initiated	2012-08-15	2012-08-08

Product code FQM

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)