The Recall Desk

FDA (Devices) recall action 83247

Epimed International, Inc. recalled 2 products on 2019-07-31

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2019-07-31
Critical
0
Units
298

Why these products were recalled

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.

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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–2 of 2

  • ModerateFDA (Devices)··2019-07-31

    Epimed Versa-Kath Mini Kit Recalled for Incorrect Catheter Size Labeling

    Epimed International is recalling 98 Versa-Kath Mini Kits because the labeling incorrectly states the kit contains a 12-gauge catheter, while it actually contains a 21-gauge catheter.

    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
    Category
    Distribution
    8 states
  • ModerateFDA (Devices)··2019-07-31

    Epimed Versa-Kath Mini Kit Recalled for Incorrect Catheter Size Labeling

    Epimed International is recalling 200 Versa-Kath Mini Kits because the labeling incorrectly states a 12-gauge catheter is included, while the kit actually contains a 21-gauge catheter.

    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
    Category
    Distribution
    8 states