Date Initiated by Firm | March 25, 2015 |
Date Posted | April 23, 2015 |
Recall Status1 |
Terminated 3 on August 21, 2015 |
Recall Number | Z-1513-2015 |
Recall Event ID |
70851 |
510(K)Number | K143625 |
Product Classification |
Unit, cryosurgical, accessories - Product Code GEH
|
Product | CSA Medical truFreeze Console- Cryosurgical Unit Cryogenic Surgical Device
Model: CC3-01 |
Code Information |
Serial Numbers: 01-00106 through 01-00201 |
Recalling Firm/ Manufacturer |
CSA Medical 91 Hartwell Ave Lexington MA 02421-3137
|
For Additional Information Contact | 781-538-4720 |
Manufacturer Reason for Recall | TruFreeze Console caused a higher rate of liquid nitrogen (cryogen) to be delivered and may cause: stricture,scarring, bradycardia, or pneumothorax |
FDA Determined Cause 2 | Software design |
Action | CSA Medical issued letter dated 3/25/15 advising users of the problem. Users provided with:
The mitigations available to the active venting procedures coupled with the extremely unlikely probability of injury, rare risk, thus allowing the physician to continue with active venting procedures.
In regards a passive venting procedure may not have sufficient mitigation to allow the physician to identify the potential hazard with sufficient time to preclude a potential for injury. Therefore, passive users will be instructed not to use the system until a software improvement is put into place. Additionally, no
catheters or consoles will be shipped to passive venting users of truFreeze.
A response form to be signed and returned confirming receipt of the notification.Questions contact: Stephen Mascioli, MD 781-538-4755 smascioli@csamedical.com. |
Quantity in Commerce | 82 units |
Distribution | Nationwide |
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 = GEH
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