Bioteque America Inc
Uterine Introducing Catheter 5F, 300 mm in length. The product is shipped in a sterile tyvek pouch
| Date | Mar 23, 2005 (initiated Feb 24, 2005) |
| Status | Terminated |
| Reason | product is marketed without a 510(k) |
| Root cause | Other |
| Action | The recalling firm telephoned the distributors and sales representatives on 2/23/05 informing them of the problem and the need to return the product. As a follow up to the telephone call, a recall letter dated 2/24/05 was issued to the distributors. |
| Quantity | 115 units |
| Distribution | The products were shipped to distributors in OH and MI. The product was also provided to sales representatives. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.