FDA-Device2019-07-31Class II
Versa - Kath Mini Kit, with plastic L.O.R Syringe 12g X 12in (30.5 cm), 5 units, Sterile ED, REF 181-2112, RX, (01) 108187880213945, LOT 31129344 for epidural or caudal anesthesia
Epimed International, Inc.
Hazard
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 included.
Sold states
Distribution in US states of CA, FL, OK, AR, WA, TX, ID, NY, South Africa, and Mexico
Affected count
98 kits
Manufactured in
141 Sal Landrio Dr, Crossroads Business Park, Johnstown, NY, United States
Products
Versa - Kath Mini Kit, with plastic L.O.R Syringe 12g X 12in (30.5 cm), 5 units, Sterile ED, REF 181-2112, RX, (01) 108187880213945, LOT 31129344 for epidural or caudal anesthesia
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2069-2019Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief