Centurion Healthcare Products Laceration Tray, sterile; (Reorder SUT8805A) Tri-State Hospital Supply Co., Howell, MI 488
FDA device recall Z-0729-2008 · posted 2008-02-23 · Terminated
Recall details
- Recalling firm
- Tri-State Hospital Supply Corporation
- Reason for recall
- Incorrect Needle size - Some of the kits contain a 1 inch 21G needle instead of the 1-1/2 inch 21G needle specified on the kit label.
- Action taken
- An Urgent Product Recall Notice was sent on October 25, 2007 to Distributors, Distributors customers, and all third party consignee. The letter provided information concerning the product recall, and requested removal of all product inventory. A product return form requesting information on products still in the facility was enclosed. A Tri-State Representative will be in contact regarding retrieval of the product.
- Root cause
- Mixed-up of materials/components
- Status
- Terminated
- Product code
- LRP
- Quantity affected
- 40 kits.
- Distribution
- Nationwide Distribution, including states of Massachusetts and Washington.
- Date initiated
- 2007-10-26
- Date posted
- 2008-02-23
- Date terminated
- 2008-03-13
- Location
- Howell, MI
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MONOJECT SAFETY NEEDLE (K012736) | Tyco Healthcare | 2001-10-25 |