Z-1955-2013Class II

Fisherbrand Sterile Swab, Calcium Alginate Fiber Tipped, Wood Applicator Swab 100 pouches/boxes, 10...

Name: Z-1955-2013 Fisherbrand Sterile Swab, Calcium Alginate Fiber Tipped, Wood Applicator Swab 100 pouches/boxes, 10...
Creator: Fisher Scientific Co
Published: 2013-06-05
License: https://open.fda.gov/license/

Fisher Scientific Company L.L.C. / initiated 2013-06-05 / Terminated / root cause: manufacturing process

FDA source

Fisher Scientific Co began a recall of Fisherbrand Sterile Swab, Calcium Alginate Fiber Tipped, Wood Applicator Swab 100 pouches/boxes, 10 boxes/case. Used in applying medications to or take... on 2013-06-05. FDA classified it as Class II and gives the reason as "The firm is recalling Fisherbrand Sterile Swabs due to 4 customer complaints reporting the presence of non-pathogenic organisms in two lots. The finding was confirmed in lot 61513 and lot 8710 is also being recalled as...". 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-1955-2013
Classification: Class II
Status: Terminated
Initiated: 2013-06-05
Posted: 2013-08-12
Terminated: 2014-10-20
Recalling firm: Fisher Scientific Company L.L.C.
Product: Fisherbrand Sterile Swab, Calcium Alginate Fiber Tipped, Wood Applicator Swab 100 pouches/boxes, 10 boxes/case. Used in applying medications to or take specimens from a patient.
Product code: KXG Applicator, Absorbent Tipped, Sterile
Reason for recall: The firm is recalling Fisherbrand Sterile Swabs due to 4 customer complaints reporting the presence of non-pathogenic organisms in two lots. The finding was confirmed in lot 61513 and lot 8710 is also being recalled as a precautionary measure.
Root cause tag: manufacturing process
FDA root cause: Material/Component Contamination
Action: Customers were notified by letter on June 18, 2013 and requested to discontinue use and return all affected product. The firm also asked that any additional affected customer base be contacted and notified of the recall if the lots had been further distributed. If you have any questions, contact Stericycle (reference "Event 4070") at 1-877-410-5558.
Quantity in commerce: 1230
Distribution: Nationwide and the country of Canada.
Product codes and lots: Product code # 14-959-81, lot #61513, expiration date: 2014-08, and lot 8710, expiration date 2014-08.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1955-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1955-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-21	2013-08-12

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)