Z-0946-2014Class II

MICROTEK(TM) MEDICAL BUR HOLE LATEX PROBE COVER W/ GEL, featuring IsoSilk(R), 5" x 98", (13cm x 249 cm), REF...

Name: Z-0946-2014 MICROTEK(TM) MEDICAL BUR HOLE LATEX PROBE COVER W/ GEL, featuring IsoSilk(R), 5" x 98", (13cm x 249 cm), REF...
Creator: Ecolab Inc
Published: 2013-07-02
License: https://open.fda.gov/license/

Microtek Medical LLC / initiated 2013-07-02 / Terminated / root cause: manufacturing process

FDA source

Ecolab Inc began a recall of MICROTEK(TM) MEDICAL BUR HOLE LATEX PROBE COVER W/ GEL, featuring IsoSilk(R), 5" x 98", (13cm x 249 cm), REF 3688, STERILE EO, QTY 20, Microtek Medical, Inc... on 2013-07-02. FDA classified it as Class II and gives the reason as "Certain lots of these Bur Hole Probe Covers did not undergo endotoxin (LAL) testing to the proper levels". 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-0946-2014
Classification: Class II
Status: Terminated
Initiated: 2013-07-02
Posted: 2014-02-10
Terminated: 2014-05-14
Recalling firm: Microtek Medical LLC
Product: MICROTEK(TM) MEDICAL BUR HOLE LATEX PROBE COVER W/ GEL, featuring IsoSilk(R), 5" x 98", (13cm x 249 cm), REF 3688, STERILE EO, QTY 20, Microtek Medical, Inc., Columbus, MS 39702
Product code: KKX Drape, Surgical, Antimicrobial
Reason for recall: Certain lots of these Bur Hole Probe Covers did not undergo endotoxin (LAL) testing to the proper levels.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: The recall was conducted to the consumer/user level. The firm notified their direct consignees of the problem and the recall by written letter mailed on July 2, 2013. The notice requested the consignees to quarantine any recalled product on hand, and complete and return the response form by July 31, 2013. The consignees who further distributed the recalled product were asked to notify their consignees.
Quantity in commerce: 2,102 individual units
Distribution: Worldwide Distribution-USA (nationwide) and the countries of Austria, Germany, Finland, Ireland, France, Spain, Great Britain, Belgium, Netherlands, Switzerland, Jordan, United Kingdom, Saudi Arabia, Hungary, Latvia, Malta, Norway, Poland, Portugal, and Canada.
Product codes and lots: Lot Numbers: D102471, D102661, D102701, D110831, D111101, D111151, D111231, D111441, D112301, D112851, D112991, D113551, D120821, D121181, D121951, D122421, D130171, D130381, D82321, D82871, D83261, D90261, D91671, DA102491, DA90491, DA90621, DA91061, and DA91671

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0946-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0943-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-19	2014-02-10
Z-0944-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-19	2014-02-10
Z-0945-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-19	2014-02-10
Z-0946-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-19	2014-02-10
Z-0947-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-19	2014-02-10
Z-0948-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-19	2014-02-10

Product code KKX

K882724Class IIMicrotek Probe DrapeMicrobio-Medics, Inc. / cleared 1988-08-03

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)