CSA Medical truFreeze System; Model: CC3-01, a cryogenic surgical device ***The involved units are those with the newest
FDA device recall Z-0941-2015 · posted 2015-01-07 · Terminated
Recall details
- Recalling firm
- CSA Medical
- Reason for recall
- An increase in complaint trending for a loss of audible sound associated with the timer has been observed.
- Action taken
- The firm, CSA Medical, sent a letter to its consignees 11/14/2014, via Fedex overnight . The letter explains the event and asks consignees to us a verbal call of time during the cryogen spray period until the root cause is determined and a permanent correction is implemented. Consignees are also asked to complete an acknowledgment form and return it to CSA Medical via, fax, email, telephone, etc.
- Root cause
- Software design
- Status
- Terminated
- Product code
- GEH
- Quantity affected
- 46
- Distribution
- US Distribution to states of: AR, CA, CO, CT, DC, FL, GA, IL, IN, LA, MA, MD, MI, NC, NJ, NY, OK, PA, RI, SC, TN, TX, UT, VA, and WV.
- Date initiated
- 2014-11-10
- Date posted
- 2015-01-07
- Date terminated
- 2015-03-25
- Location
- Lexington, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TRUFREEZE SYSTEM (K133258) | CSA Medical, Inc. | 2014-06-19 |