Reusable Catheter Passer (60 cm) SP02. One stainless steel catheter passer with T handle.
This recall has been terminated (originally issued November 27, 2003).
- Company
- Vygon Us Llc
- Recall Initiated
- September 9, 2003
- Posted
- November 27, 2003
- Terminated
- November 26, 2003
- Recall Number
- Z-0161-04
- Quantity
- 26 units
- Firm Location
- Norristown, PA
- Official Source
- View on FDA website ↗
Reason for Recall
mislabeled as sterile
Distribution
The products were shipped to one distributor in NY and two hospitals in TX and UT. The products were also shipped to distributors in Holland, Greece, Austria, Norway, Taiwan, and Finland.
Lot / Code Info
Catalog number SP02. Lot numbers H0266, H0464, H0565, H0650, I0195, J0288, J0108, J0494, K0701, and K0929.
Root Cause
Other
Action Taken
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.