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
Reported: July 31, 2019 Initiated: June 18, 2019 #Z-2068-2019
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.
Details
- Recalling Firm
- Epimed International, Inc.
- Units Affected
- 200 kits
- Distribution
- Distribution in US states of CA, FL, OK, AR, WA, TX, ID, NY, South Africa, and Mexico
- Location
- Johnstown, NY
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Epimed International, Inc.. Units affected: 200 kits.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 31, 2019. Severity: Moderate. Recall number: Z-2068-2019.
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