Vygon US LLC Reusable Catheter Passer (40 cm) SP01. One stainless steel catheter passer with T handle. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Reusable Catheter Passer (40 cm) SP01. One stainless steel catheter passer with T handle.
Brand
Vygon US LLC
Lot Codes / Batch Numbers
Catalog number SP01, Lot numbers H0359, J0107, and J0493.
Products Sold
Catalog number SP01, Lot numbers H0359, J0107, and J0493.
Vygon US LLC is recalling Reusable Catheter Passer (40 cm) SP01. One stainless steel catheter passer with T handle. due to mislabeled as sterile. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
mislabeled as sterile
Recommended Action
Per FDA guidance
The recalling firm issued recall letters to their direct accounts via fax on 9/9/03. The letter informed the accounts of the problem and the need to sterilize the product or return it for replacements.
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, NY, TX, UT
Page updated: Jan 10, 2026