Recall Z-2043-2025 ยท LRO General Surgery Tray
MEDLINE INDUSTRIES, LP - Northfield
Medline convenience kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN. labeled as: 1) CC DRAWER 4 IV CIRCULATION, REF ACC010254B; 2) CC ADULT DRAWER 2, REF ACC010256; 3) PEDI EMERGENCY TRAY-BLUE, REF ACC010316A; 4) ADULT DRAWER 4, REF ACC010389C; 5) DRAWER 4 - SUMMIT, REF ACC010627; 6) DRAWER 3, REF ACC010898.
| Date | Jun 30, 2025 (initiated May 23, 2025) |
| Status | Open, Classified |
| Reason | Medline Industries, LP. is issuing a recall for specific Medline kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN which was identified that during insertion of the Catheter, the needle is slow to retract or fails to retract. |
| Root cause | Under Investigation by firm |
| Action | Medline Industries issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 05/23/2025 via email and USPS mail. The notice explained the issue, risk, and requested the following: "REQUIRED ACTION: 1.Immediately check your stock for the affected item number(s) and the affected lot number(s) listed within the recall portal. Quarantine all affected product.2.Please use the link and the information below to complete your response form. Please list the quantity of affected product you have in inventory on the form. Even if you do not have any affected product in inventory, please compl |
| Quantity | 186 units |
| Distribution | US Nationwide distribution in the states of IN, KY, CA, MI, TX, WA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.