Date Initiated by Firm | October 25, 2012 |
Date Posted | November 20, 2012 |
Recall Status1 |
Terminated 3 on November 20, 2012 |
Recall Number | Z-0406-2013 |
Recall Event ID |
63596 |
510(K)Number | K090584 |
Product Classification |
System, therapeutic, x-ray - Product Code JAD
|
Product | INTRABEAM Balloon Applicator Set;
4.0 cm,
Carl Zeiss Meditec AG, Oberkochen, Germany
INTRABEAM System is intended for radiation therapy treatments. |
Code Information |
Part number 304534-7500-002; lot number 540960. |
Recalling Firm/ Manufacturer |
Carl Zeiss Meditec, Inc. 5160 Hacienda Dr Dublin CA 94568-7562
|
For Additional Information Contact | Judith A. Brimacombe, M.A 925-557-4616 |
Manufacturer 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. |
FDA Determined Cause 2 | Nonconforming Material/Component |
Action | 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. |
Quantity in Commerce | 36 total, all lots |
Distribution | Nationwide Distribution including IL and MD |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = JAD
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