Z-2068-2019Class II

Versa - Kath Mini Kit, with plastic L.O.R Syringe 12g X 12in (30.5 cm), 5 units, Sterile ED, REF 181-2112...

Name: Z-2068-2019 Versa - Kath Mini Kit, with plastic L.O.R Syringe 12g X 12in (30.5 cm), 5 units, Sterile ED, REF 181-2112...
Creator: Epimed International, Inc.
Published: 2019-06-18
License: https://open.fda.gov/license/

Epimed International, Inc. / initiated 2019-06-18 / Terminated / root cause: labeling and UDI

FDA source

Epimed International, Inc. began a 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 311291155 for epidural... on 2019-06-18. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2068-2019
Classification: Class II
Status: Terminated
Initiated: 2019-06-18
Posted: 2019-07-24
Recalling firm: Epimed International, Inc.
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 311291155 for epidural or caudal anesthesia
Product code: BSO Catheter, Conduction, Anesthetic
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.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: On June 19, 2019 , the firm mailed a lot specific, medical device market correction letter, via USPS to consignees who received the affected product(s). The letter asked customers to do the following: 1. Please examine your inventory and quarantine any product subject to the recall immediately. 2. Once product has been Quarantined, please complete and return the response form as soon as possible. 3. Please contact EPIMED sales administrative assistance, Bobbi Harrington at (518) 725-0209 ext. 1200 or [email protected], so that immediate replacement or credit for the affected product can be arranged. 4. If you have any questions, please contact Mr. Kris Knapp at 1-800-866-3342 ext. 1305.
Quantity in commerce: 200 kits
Distribution: Distribution in US states of CA, FL, OK, AR, WA, TX, ID, NY, South Africa, and Mexico
Product codes and lots: Lot 31129155, Exp: 2022-12-31

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2068-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2068-2019	Class II	Terminated	Voluntary: Firm initiated	2019-07-31	2019-07-24
Z-2069-2019	Class II	Terminated	Voluntary: Firm initiated	2019-07-31	2019-07-24

Product code BSO

K023140Class IIVersa-Kath Epidural Catheter, Model 156-2124Epimed International, Inc. / cleared 2003-08-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)