FDA Recall
Terminated
Uterine Introducing Catheter 5F, 300 mm in length. The product is shipped in a sterile tyvek pouch
Recall: Z-0027-05
·
Initiated February 24, 2005
Recall
- Recall Number
- Z-0027-05
- Event Number
- 31276
- Firm
- Bioteque America Inc
- FEI Number
- 1000121341
- Status
- Terminated
- Root Cause
- Other
- Initiated
- February 24, 2005
- Posted
- March 23, 2005
- Terminated
- June 14, 2005
- Address
- 340 E Maple Ave, Ste 204c, Langhorne, PA, 19047-2848
Description
Uterine Introducing Catheter 5F, 300 mm in length. The product is shipped in a sterile tyvek pouch
Reason
product is marketed without a 510(k)
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.
Distribution
The products were shipped to distributors in OH and MI. The product was also provided to sales representatives.
Quantity
115 units