Stackhouse Lens/Hood, Mark III Universal; a sterile disposable protective head garment for use with the Stackhouse Mark
FDA device recall Z-0002-06 · posted 2005-10-04 · Terminated
Recall details
- Recalling firm
- VIASYS Med Systems
- Reason for recall
- The packaging may be compromised such that sterility of the hoods cannot be guaranteed.
- Action taken
- VIASYS telephoned the direct accounts and sent out follow-up faxes on 9/13/05. The accounts were informed of the potential for compromised packages seals and questionable sterility, and were instructed to check their inventory for the affected catalog numbers and lots numbers. The accounts were instructed to hold any affected product and contact VIASYS at 1-800-323-6305 to arrange for the return goods authorization. The dealers were requested to sub-recall the affected product from their customers.
- Root cause
- Other
- Status
- Terminated
- Product code
- FXY
- Quantity affected
- 125 cases
- Distribution
- Nationwide and internationally to Japan, Chile and Switzerland
- Date initiated
- 2005-09-13
- Date posted
- 2005-10-04
- Date terminated
- 2005-12-30
- Location
- Wheeling, IL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| FREEDOM MARK III SURGICAL HELMET SYSTEM (K910515) | Stackhouse Assoc. | 1991-05-06 |