FDA recall Z-2069-2019

Product

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

Reason for recall

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.

Distribution

Distribution in US states of CA, FL, OK, AR, WA, TX, ID, NY, South Africa, and Mexico

Key facts

Status

Terminated

Initiation date

2019-06-18

Report date

2019-07-31

Voluntary/Mandated

Voluntary: Firm initiated

Location

Johnstown, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2069-2019