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
FDA Recall Z-2069-2019 · Posted None
Advertisement
Recalling FirmEpimed International, Inc.
Recall StatusTerminated
Product CodeBSO
Date Initiated2019-06-18
Product Quantity98 kits
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.
Firm 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.
Root Cause
Labeling mix-ups
Distribution Pattern
Distribution in US states of CA, FL, OK, AR, WA, TX, ID, NY, South Africa, and Mexico
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement