CMS-MST572 5F insertion kit with 5 cm tearaway. The product is shipped 10 kits per box and is intended for use in percut
FDA device recall Z-1909-2008 · posted 2008-09-16 · Terminated
Recall details
- Recalling firm
- Medical Components, Inc dba MedComp
- Reason for recall
- kit contains incorrect component
- Action taken
- The recalling firm issued recall letters on 4/11/08 via UPS delivery. The letters informed the customers of the problem and the need to return the product.
- Root cause
- Mixed-up of materials/components
- Status
- Terminated
- Product code
- DQX
- Quantity affected
- 100 units
- Distribution
- The products were shipped to customers in PA and TX.
- Date initiated
- 2008-04-11
- Date posted
- 2008-09-16
- Date terminated
- 2008-10-28
- Location
- Harleysville, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GALT MEDICAL GUIDEWIRE (K031916) | Galt Medical Corp. | 2003-07-17 |