Recall Z-1129-2023 ยท FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Access Vascular, Inc
HydroMID 4Fr Single Lumen - Basic Kit, Model Number 80004002
| Date | Feb 10, 2023 (initiated Dec 16, 2022) |
| Status | Open, Classified |
| Reason | Select catheter lots were identified to be labeled with incorrect expiration date, where the catheters expire prior to the labeled expiration date of the kit. |
| Root cause | Incorrect or no expiration date |
| Action | Urgent Medical Device Correction notification letters were sent to customers beginning 12/16/22.. Access Vascular has identified that the catheter packaged with specific lots of the HydroPICC Kits and HydroMID Kits have a shorter expiration date than what is listed on the outer kit package. These catheters are individually packaged and supplied sterile along with a sterile kit. Our records indicate that your facility has received kits from the affected lots. We are contacting you to provide information on action to take to ensure patient safety. - Product that has already been used: No actio |
| Quantity | 1,789 HydroMID devices |
| Distribution | US Nationwide distribution in the states of CT, IL, IN, MA, NE, TN, and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K203069 | HydroMID Access Vascular, Inc., Feb 8, 2021 |