Z-1521-2014Class II

Fisherbrand Sterile Swabs, Calcium Alginate Fiber Tipped Aluminum Applicator Swab, .025 and .035 in Diameter...

Name: Z-1521-2014 Fisherbrand Sterile Swabs, Calcium Alginate Fiber Tipped Aluminum Applicator Swab, .025 and .035 in Diameter...
Creator: Fisher Scientific Co
Published: 2014-02-05
License: https://open.fda.gov/license/

Fisher Scientific Company L.L.C. / initiated 2014-02-05 / Terminated / root cause: manufacturing process

FDA source

Fisher Scientific Co began a recall of Fisherbrand Sterile Swabs, Calcium Alginate Fiber Tipped Aluminum Applicator Swab, .025 and .035 in Diameter, all lots, 100 per pack Fisherbrand Sterile Swabs... on 2014-02-05. FDA classified it as Class II and gives the reason as "A customer reported the presence of an organism in a lot of Calcium Alginate Fiber Tipped Wood Applicator Swab". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1521-2014
Classification: Class II
Status: Terminated
Initiated: 2014-02-05
Posted: 2014-04-28
Terminated: 2015-08-10
Recalling firm: Fisher Scientific Company L.L.C.
Product: Fisherbrand Sterile Swabs, Calcium Alginate Fiber Tipped Aluminum Applicator Swab, .025 and .035 in Diameter, all lots, 100 per pack Fisherbrand Sterile Swabs, Calcium Alginate Fiber Tipped Plastic Applicator Swab, all lots, 100 per pack Fisherbrand Sterile Swabs, Calcium Alginate Fiber Tipped Wood Applicator Swab, all lots, 100 and 200 per pack culture collection and industrial surfaces
Product code: KXG Applicator, Absorbent Tipped, Sterile
Reason for recall: A customer reported the presence of an organism in a lot of Calcium Alginate Fiber Tipped Wood Applicator Swab.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Fisher Scientific sent an Urgent: Medical Device Recall/Return letter dated March 18, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. ACTIONS TO BE TAKEN BY THE USER OR DISTRIBUTOR: Fisher Scientific requests that you discontinue use and distribution of all products referenced above. We also request that you return all product (opened and unopened) as soon as possible. A credit will be issued for returned product. User: Fisher Scientific requests that you complete the Acknowledgment Form enclosed with this letter, even if you do not have the above mentioned product(s) in your inventory, within three (3) working days. Distributor: Our records indicate that you may have purchased one or more of the above products for re-sale to your customers. You should complete the attached Acknowledgment Form for inventory you have received and/or which is still in stock. Fisher Scientific requests that you complete and return the Acknowledgment Form enclosed with this letter, even if you do not have the above mentioned catalog numbers in your inventory, within three (3) working days. In addition, please contact your affected customer base to advise them of the expanded recall, by providing them with a copy of this letter. You should insert your contact information, email and fax numbers in the Acknowledgment Form and request that your customer return the Acknowledgment Form to you, and you notify us of the information conveyed in such Acknowledgment Form(s). ACTION BY FISHER SCIENTIFIC: Fisher Scientific has no inventory of the affected products as it was discontinued in May 2013. However, we do have alternative products that we can recommend as replacements. Please contact customer service for information on product alternatives. We appreciate your immediate attention to this expanded voluntary recall. By returning the attached Acknowledgment Form you wil
Quantity in commerce: 7430
Distribution: Nationwide Distribution
Product codes and lots: all lots of article nos. 14-959-77, 14-959-78, 14-959-79, 14-959-81, 14-959-82, lots 60151, 61513, 61933, 62768, 63055, 60752, 61324, 62195, 63224, 60752, 62195, 61866, 62546, 8710, with expiration dates August 2014 through October 2015

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1521-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1521-2014	Class II	Terminated	Voluntary: Firm initiated	2014-05-07	2014-04-28

Product code KXG

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)