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Endo-Scrub2 - Sheath and Tubing Set (2014-03-13)
- Starting date:
- March 13, 2014
- Posting date:
- April 14, 2014
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-39007
Recalled Products
A. Endo-Scrub 2 Sheath
B. Endo-Scrub 2 Tubing Set
Reason
The luer connector on the end of the tubing that attaches to the sheath may break off, either prior to or during use. Once the connector breaks, the flow of saline to the sheath either ceases or is reduced and leakage occurs at the fracture site.
Affected products
A. Endo-Scrub 2 Sheath
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
More than 10 numbers, contact manufacturer
Companies
- Manufacturer
-
Medtronic-Xomed Inc.
6743 Southpoint Drive North
Jacksonville
32216
Florida
UNITED STATES
B. Endo-Scrub 2 Tubing Set
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
1912030
Companies
- Manufacturer
-
Medtronic Xomed Inc.
6743 Southpoint Drive North
Jacksonville
32216
Florida
UNITED STATES