"***REF NL82059-03***INTEGRA NEUROSCIENCES***Touhy Needle***Non Sterile for Single Use Only***14g, 6"***Plainsboro, NJ**
FDA device recall Z-1050-2012 · posted 2012-02-16 · Terminated
Recall details
- Recalling firm
- Integra Neurosciences PR, Inc.
- Reason for recall
- The current packaging configuration for the non-sterile shunt accessories could lead to the potential for confusion regarding product sterility.
- Action taken
- Integra sent an Urgent Product Recall Notification letter dated November 28, 2011. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to fill out and sign the attached Recall Acknowledgement Form noting the part numbers, lot numbers and quantity of the affected product in their inventory. Customers were asked to contact Integra LifeSciences Corporation International Customers Service at 609-936-5400 to arrange for Returns. If customers do not have any of the affected product in their inventory they are required to complete and sign the form and indicate they have NO affected product in their inventory. Customers should fax or email their Recall Acknowledgement Form to: 609-750-4259 or LAPAC_CS@Integralife.com For questions call 609-936-2495.
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- JXG
- Quantity affected
- 357 units
- Distribution
- Worldwide Distribution - USA (nationwide) and the countries of Austria, Canada, Italy, Australia
- Date initiated
- 2011-11-28
- Date posted
- 2012-02-16
- Date terminated
- 2013-10-29
- Location
- Anasco, PR
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HEYER-SCHULTE SYRINGO PERITONEAL SHUNT (K854049) | American V. Mueller | 1985-11-27 |
| SPETZLER LUMBAR-PERITONEAL SYSTEM (K811288) | American Heyer Schulte | 1981-06-26 |