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Bur Hole Latex Free Probe Covers with Gel (2013-07-02)
- Starting date:
- July 2, 2013
- Posting date:
- October 25, 2013
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-36417
Recalled Products
A. Bur Hole Latex Free Probe Cover with Gel
B. Bur Hole Latex Probe Cover with Gel
Reason
Affected lots did not undergo endotoxin (LAL) testing to the proper levels. If this product is used in contact with the central nervous system, paitents might be exposed to endotoxin levels above prescribed limits.
Affected products
A. Bur Hole Latex Free Probe Cover with Gel
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
- PC3688
Companies
- Manufacturer
-
Microtek Medical, Inc.
512 Lehmberg Road
Columbus
39702
Ohio
UNITED STATES
B. Bur Hole Latex Probe Cover with Gel
Lot or serial number
- D110831
- D111441
- D112301
- D120821
- D83261
- D91671
- DA90621
- DA91061
- DA91671
Model or catalog number
- 3688