Ultrakleen KSponge II Spears Catalog #: K20-5012
FDA device recall Z-0487-03 · posted 2003-01-30 · Terminated
Recall details
- Recalling firm
- Ultracell Medical Technologies
- Reason for recall
- Sterility of the device is compromised
- Action taken
- Ultracell Medical Technologies initiated the recall by fax or mail on 1/8/03. The firm requested return of product . Distributors were requestd to recall to their accounts.
- Root cause
- Other
- Status
- Terminated
- Product code
- HOZ
- Quantity affected
- 4,047 units
- Distribution
- Nationwide
- Date initiated
- 2003-01-08
- Date posted
- 2003-01-30
- Date terminated
- 2012-05-01
- Location
- North Stonington, CT
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SURGICAL SPEARS (K923922) | Ultracell Medical Technologies, Inc. | 1993-03-19 |