Kendall Kerlix A.M.D. Antimicrobial Large Roll, Sterile 6 ply-4.5 in x 4.1 yd Product Number: 3331
FDA device recall Z-0380-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Kendall Healthcare Products Co
- Reason for recall
- Sterility compromised due to lack of package seal integrity
- Action taken
- Kendall issued Recall letters by US Mail to all customers on January 8, 2004, requesting product be returne and dealer customers be notified.
- Root cause
- Other
- Status
- Terminated
- Product code
- NAD
- Quantity affected
- 1 case
- Distribution
- AL, AZ, CA, CO, FL, GA, IL, KY, LA, MA, MD, MN, MO,NC NE, NJ, NY, OH, PA, RI, TN, TX, VA, WA, WI, WV.
- Date initiated
- 2004-01-08
- Date posted
- 2004-07-20
- Date terminated
- 2012-05-15
- Location
- Mansfield, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| KERLIX MD ANTIMICROBIAL GAUZE DRESSING (K990530) | The Kendall Company, L.P. | 2000-01-31 |