INTRABEAM Balloon Applicator Set; 3.0 cm, Carl Zeiss Meditec AG, Oberkochen, Germany INTRABEAM System is intended for ra
FDA device recall Z-0404-2013 · posted 2012-11-20 · Terminated
Recall details
- Recalling firm
- Carl Zeiss Meditec, Inc.
- Reason for recall
- A manufacturing defect has been identified which could results in the small tube becoming dislodged between the luer fitting and the check valve.
- Action taken
- Carl Zeiss Meditec sent an Important Field Corrective Action letter dated October 25, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately return the affected product to Carl Zeiss Meditec, Inc. A Carl Zeiss Meditec representative will contact the customer to schedule a visit to support the removal of the affected product. For questions customers were instructed to call 925-580-5371 or by email at v.venturo@meditec.zeiss.com. For questions regarding this recall call 925-557-4616.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- JAD
- Quantity affected
- 36 tootal, all lots
- Distribution
- Nationwide Distribution including IL and MD
- Date initiated
- 2012-10-25
- Date posted
- 2012-11-20
- Date terminated
- 2012-11-20
- Location
- Dublin, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| INTRABEAM SYSTEM WITH BALLOON APPLICATOR AND CBG SETS (K090584) | Carl Zeiss Surgical GmbH | 2009-11-24 |