Recall Z-0946-2014 ยท KKX Drape, Surgical, Antimicrobial
Ecolab Inc
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
| Date | Feb 10, 2014 (initiated Jul 2, 2013) |
| Status | Terminated |
| Reason | Certain lots of these Bur Hole Probe Covers did not undergo endotoxin (LAL) testing to the proper levels. |
| 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 | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K882724 | MICROTEK PROBE DRAPE Microbio-Medics, Inc., Aug 3, 1988 |