Z-2068-2019 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- July 31, 2019
- Initiation Date
- June 18, 2019
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 200 kits
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.
Distribution Pattern
Distribution in US states of CA, FL, OK, AR, WA, TX, ID, NY, South Africa, and Mexico
Code Information
Lot 31129155, Exp: 2022-12-31