Smith & Nephew ACUFEX Rap-Pac ACL Accessory Kit, Sterile Catalog Number: 014725
FDA device recall Z-0413-03 · posted 2003-01-09 · Terminated
Recall details
- Recalling firm
- Smith & Nephew, Inc.
- Reason for recall
- Potential for non sterility as package tray does not contain aeration holes for ETO processing.
- Action taken
- Smith & Nephew notified customers by letter on 11/8/02. Users are requested to remove stock and return to Smith & Nephew.
- Root cause
- Process control
- Status
- Terminated
- Product code
- HRX
- Quantity affected
- 77 units
- Distribution
- Nationwide: AL, CA, IL, KY, FL, GA, IN, ME, MI, NH,NY, OH, SC, TX, WV,
- Date initiated
- 2002-11-08
- Date posted
- 2003-01-09
- Date terminated
- 2005-04-20
- 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 |
|---|---|---|
| ACUFEX PRO-PAC AND ISO-PAC (K931621) | Acufex Microsurgical, Inc. | 1994-01-21 |