FDA: Medtronic voluntary recall of catheter is Class I recall
Device Regulation Alert: Safety, Compliance and Reimbursement News, April 13, 2009
The FDA is classifying Medtronic’s voluntary recall for three models of the BioGlide Ventricular Snap Shunt Catheter as a Class I recall, according to a company release.
A Class I recall is issued when “there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.”
Read more about Medtronic’s Class I recall.
Related Products
-
ePharm5 InDepth
EPharm5 e-mail newsletter delivers the top 5 developments in pharma business innovation, with original research, interviews...
-
Medical Environment Update
Timely medical compliance news from OSHA, CDC, EPA, and other regulatory agencies!
-
Bloodborne Pathogens Training Video
Meets OSHA requirements for training employees on the bloodborne pathogens standard!
-
Hazard Communication Standard Training Video
Meets OSHA requirements for training employees on the Hazard Communication Standard!
-
Needlestick Prevention Training Video
Highlighting the five most frequent needlestick scenarios, this training video instructs frontline healthcare staff on on...
Most Popular
- Articles
-
- HIPAA Q&A: Flu shot requirement for hospital employees
- Running an effective peer review committee meeting
- HealthDataInsights posts new issues for medical necessity claims
- Sneak Peek: Effort underway to establish caseload benchmarks
- Q/A: Coding for telescopic intraocular lens
- New FAQ posted on storing laryngoscope blades
- Tip: Perform your own internal investigation prior to government audit
- HIPAA 5010 deadline extended, but threat remains, says AMA
- HHS task force: Consider privacy, security with text messages
- What does case-mix index mean to you?
- E-mailed
-
- Running an effective peer review committee meeting
- HIPAA Q&A: Flu shot requirement for hospital employees
- HHS task force: Consider privacy, security with text messages
- What does case-mix index mean to you?
- Q/A: Coding for telescopic intraocular lens
- Q/A: Correct use of modifier -PT
- Tip: Correctly code bilateral pain management procedures
- "Wall fountains" may be spreading Legionnaires to patients, visitors
- 2012 CPT code changes for ASCs: Shoulder and knee scopes and pain management
- COT basics to best
- Searched