31144 Combo Kit including 1 Cranial Kit w/Cam Chuck, 1 Micro Ventricular Bolt ICP, 1 CSF Drainage System, contains steri
FDA device recall Z-0756-2012 · posted 2012-01-13 · Terminated
Recall details
- Recalling firm
- Integra LifeSciences Corp. d.b.a. Integra Pain Management
- Reason for recall
- Current package insert was revised to include additional warning information related to the potential hazards of an unapproved off-label use of Xylocaine.
- Action taken
- Integra sent an Urgent: Medical Device Correction Notice letter dated December 21, 2011 to all affected customers. The letter identified the product, problem and actions to be taken. Integra is requesting that customers further distribute the communications along with the package insert to all appropriate health care practitioners at their facility. The letter instructs customers to complete and return the attached acknowledgement form by fax to 609-750-7999. For questions or concerns call 609-750-2814.
- Root cause
- Labeling False and Misleading
- Status
- Terminated
- Product code
- HBG
- Quantity affected
- 62 units.
- Distribution
- (USA) Nationwide Distribution
- Date initiated
- 2011-12-21
- Date posted
- 2012-01-13
- Date terminated
- 2012-05-10
- Location
- Salt Lake City, UT
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CNS INTERCHANGEABLE BIT CRANIAL DRILL (K961113) | Clinical Neuro Systems, LLC | 1996-06-05 |