FDA Medical Device Recalls (openFDA)
Epimed International, Inc.: 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
- Recall number
- Z-2069-2019
- 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 31129344 for epidural or caudal anesthesia
- Status
- Terminated
- Initiated
- 2019-06-18
- Posted
- not on file
- Terminated
- not on file
- 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.
- 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 bobbih@epimed.com, 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
- 98 kits
- Distribution
- Distribution in US states of CA, FL, OK, AR, WA, TX, ID, NY, South Africa, and Mexico
- Lot, serial or model codes
- Lot 31129344 Exp: 2023-06-30
- 510(k) numbers
- ["K023140"]
- PMA numbers
- not on file
- Product code
- BSO
- Firm FEI
- 1316297
- Firm city
- Johnstown
- Firm state
- NY
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28