Device 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
Z-2069-2019
Product summary
- Event
- Event 83247
- Status
- Terminated
- Classification
- Class II
- Quantity
- 98 kits
- Official record key
device-enforcement:Z-2069-2019
Official wording
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.
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
Derived failure modes
-
Labeling or packaging
Mislabeled