Recall Z-2068-2019 ยท BSO Catheter, Conduction, Anesthetic
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 311291155 for epidural or caudal anesthesia
| Date | Jun 18, 2019 |
| Status | Terminated |
| 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 |
| Quantity | 200 kits |
| Distribution | Distribution in US states of CA, FL, OK, AR, WA, TX, ID, NY, South Africa, and Mexico |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K023140 | VERSA-KATH EPIDURAL CATHETER, MODEL 156-2124 Epimed International, Inc., Aug 15, 2003 |