MICROTEK(TM) MEDICAL BUR HOLE LATEX FREE PROBE COVER, featuring IsoSilk(R), 13cm x 244 cm, 5" x 96", REF PC3688N, QTY 10
FDA device recall Z-0943-2014 · posted 2014-02-10 · Terminated
Recall details
- Recalling firm
- Ecolab Inc
- Reason for recall
- Certain lots of these Bur Hole Probe Covers did not undergo endotoxin (LAL) testing to the proper levels.
- Action taken
- 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.
- Root cause
- Process design
- Status
- Terminated
- Product code
- KKX
- Quantity affected
- 1800 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,
- Date initiated
- 2013-07-02
- Date posted
- 2014-02-10
- Date terminated
- 2014-05-14
- Location
- Saint Paul, MN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MICROTEK PROBE DRAPE (K882724) | Microbio-Medics, Inc. | 1988-08-03 |