FDA Device recall Z-2069-2019
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 31…
- FDA Device
- Class II
- terminated
- Published 2019-07-31
On 2019-07-31 the FDA classified a Class II recall of 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 31… by Epimed International, citing 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 c….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2069-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-06-18 |
| Published | 2019-07-31 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Epimed International |
| Distribution | AR, CA, FL, ID, NY, OK, TX, WA |
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
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.
Identifiers
| code_info | Lot 31129344 Exp: 2023-06-30 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2069-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.