Kimberly Clark * Universal Block Tray * Single Use * Sterile * Rx only * Manufactured by Ballard Medical Products, Drape
FDA device recall Z-0869-06 · posted 2006-05-16 · Terminated
Recall details
- Recalling firm
- Kimberly-Clark Corporation
- Reason for recall
- Procedural Trays may contain extension sets that do not meet USP specification requirements for non pyrogenicity (less than or equal to 2.25 EU/device (Endotoxin Units/device).
- Action taken
- Consignees were notified via fax on/about 03/15/2006.
- Root cause
- Other
- Status
- Terminated
- Product code
- CAZ
- Quantity affected
- 2320 each
- Distribution
- Nationwide. AK, AL, CA, CO, CT, FL, GA, IL, IN, LA, MA, MD, ME, MI, MN, NC, NJ, NY, OK, OR, PA, TX, UT, WA, WI.
- Date initiated
- 2006-03-15
- Date posted
- 2006-05-16
- Date terminated
- 2011-05-10
- Location
- Roswell, GA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LOCAL PLEXUS BLOCK ANESTHESIA CATHETER KITS (K904440) | Preferred Medical Products | 1991-06-07 |