Device product
MICROTEK(TM) MEDICAL BUR HOLE LATEX FREE PROBE COVER W/ GEL, featuring IsoSilk(R), 13cm x 244 cm, 5" x 96", REF PC3688EU, STERILE EO, QTY 20, Microtek Medical, Inc., Columbus, MS 39702
Z-0945-2014
Product summary
- Firm
- Ecolab Inc
- Event
- Event 65667
- Status
- Terminated
- Classification
- Class II
- Quantity
- 12,546 individual units
- Official record key
device-enforcement:Z-0945-2014
Official wording
Reason: Certain lots of these Bur Hole Probe Covers did not undergo endotoxin (LAL) testing to the proper levels.
Code information: Lot Numbers: 126429V, 126602V, 126611V, 126612V, 126613V, 126614V, 127176V, 127182V, 127331V, 127382V, 137533V, 137826V, 137967V, 137666V, 137787V, and 137817V
Distribution pattern: 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.
Derived failure modes
-
Unknown
Certain lots of these Bur Hole Probe Covers did not undergo endotoxin (LAL) testing to the proper levels.