Bioteque America Inc Uterine Introducing Catheter 5F, 300 mm in length. The product is shipped in a sterile tyvek pouch Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Uterine Introducing Catheter 5F, 300 mm in length. The product is shipped in a sterile tyvek pouch
Brand
Bioteque America Inc
Lot Codes / Batch Numbers
Lot number 741105 exp 11/07
Products Sold
Lot number 741105 exp 11/07
Bioteque America Inc is recalling Uterine Introducing Catheter 5F, 300 mm in length. The product is shipped in a sterile tyvek pouch due to product is marketed without a 510(k). Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
product is marketed without a 510(k)
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
IN, MI, OH
Page updated: Jan 10, 2026