Recall Z-1049-2025 ยท LRO General Surgery Tray
MEDLINE INDUSTRIES, LP - Northfield
MEDLINE ARTERIAL LINE PACK, REF DYNJ65208B, medical convenience kit containing Infusion Catheter with Antimicrobial Heparin Coating.
| Date | Jan 29, 2025 (initiated Dec 23, 2024) |
| Status | Open, Classified |
| Reason | Certain lots Sterile Infusion Catheters which were mislabeled as having a heparin coating were either distributed or manufactured into medical convenience kits and distributed. |
| Root cause | Process change control |
| Action | Medline Industries, LP issued one IMMEDIATE ACTION REQUIRED notice and one MEDICAL DEVICE RECALL notice to its affected consignees on 12/23/2024 via email and US Mail. The IMMEDIATE ACTION REQUIRED notice explained the labeling issue with the device, potential risk, and requested the following actions be taken: 1. affected catheters be quarantined, 2. respond with quantity on hand, 3. if the product was transferred to notify those to whom the affected catheters were transferred. Upon receipt of the response. Medline will issue corrected labeling to affix to the devices. The MEDICAL DE |
| Quantity | 50 units |
| Distribution | US: FL, KS, ND, PA, WA, WV, IL, WA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K213481 | Medline General Surgery Tray Medline Industries, Inc., May 24, 2022 |