CLASS II Device recall · Reported 31 Jul 2019 · FDA Enforcement Report
Versa - Kath Mini Kit, with plastic L.O.R Syringe, Sterile ED recalled
Epimed International is recalling Versa - Kath Mini Kit, with plastic L.O.R Syringe, Sterile ED, distributed in 8 states. The recall was initiated on 18 Jun 2019 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2069-2019
- FDA event ID
- 83247
- Recalling firm
- Epimed International, Johnstown, NY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 18 Jun 2019
- FDA classified
- 24 Jul 2019
- Reported
- 31 Jul 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
- Device type
- Syringes & Needles
Timeline
| 18 Jun 2019 | Recall initiated by company | |
| 24 Jul 2019 | Classified by FDA | +36 days |
| 31 Jul 2019 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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
Where it was distributed
Distribution in US states of CA, FL, OK, AR, WA, TX, ID, NY, South Africa, and Mexico
ArkansasCaliforniaFloridaIdahoNew YorkOklahomaTexasWashington
Questions about this recall
Is Versa - Kath Mini Kit, with plastic L.O.R Syringe, Sterile ED recalled?
Yes. Epimed International recalled Versa - Kath Mini Kit, with plastic L.O.R Syringe, Sterile ED on 18 Jun 2019. The recall is Class II and its status is Terminated. Recall number Z-2069-2019.
Why was it 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 lots are affected?
Lot 31129344 Exp: 2023-06-30
Where was it sold?
Distribution in US states of CA, FL, OK, AR, WA, TX, ID, NY, South Africa, and Mexico
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Epimed International
All 11| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Neo-kath Epidural Catheter Set recalled by Epimed International | Epimed International | Sterility | Nationwide |
| Device | CLASS II | Neo-kath(TM) Caudal Set recalled by Epimed International | Epimed International | Sterility | Nationwide |
| Device | CLASS II | Feth-R-Kath Catheter recalled by Epimed International | Epimed International | Device Malfunction | Nationwide |
| Device | CLASS II | R-F Injector Cannula recalled by Epimed International | Epimed International | Sterility | Nationwide |
| Device | CLASS II | R-F Injector Cannula recalled by Epimed International | Epimed International | Sterility | Nationwide |
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