Epimed International Feth-R-Kath Catheter, 19g x 24" recall — FDA Z-1276-2021
Outer coating of the catheter may deteriorate and result in the coating to crack and/or potentially flake off
Overview of recall records associated with Epimed International, Inc., including dates, categories and classifications where available.
Classification mix: Class II: 3.
Outer coating of the catheter may deteriorate and result in the coating to crack and/or potentially flake off
Mislabeled - The product's labeling contains an incorrect size for the catheter included in the kit. The kit contains a 21 gauge catheter, however the labeling states a 12 gauge catheter is…
Mislabeled - The product's labeling contains an incorrect size for the catheter included in the kit. The kit contains a 21 gauge catheter, however the labeling states a 12 gauge catheter is…
This page summarizes recall records in which the official source identifies Epimed International, Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.