Epimed International, Inc.: Medical Device Recall in 2019 - (Recall #: Z-2069-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: June 18, 2019

Date Posted: July 31, 2019

Recall Number: Z-2069-2019

Event ID: 83247

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.

Status: Terminated

Product Quantity: 98 kits

Code Information:

Lot 31129344 Exp: 2023-06-30

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated