Recall Z-2068-2019— Epimed International, Inc.

Name: FDA recall Z-2068-2019
Creator: U.S. Food and Drug Administration
Published: 2019-06-18

Class II · Terminated

Class II FDA medical device recall by Epimed International, Inc., initiated 2019-06-18. It names one FDA 510(k) clearance: K023140. 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 311291155 for epidural or caudal anesthesia. Reason: 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..

Recalling firm: Epimed International, Inc.
Classification: Class II
Status: Terminated
Initiated: 2019-06-18
Firm location: Johnstown, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K023140 — VERSA-KATH EPIDURAL CATHETER, MODEL 156-2124Epimed International, Inc.·cleared 2003-08-15

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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 311291155 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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.