Recall Z-0796-2025 ยท GCX Apparatus, Suction, Operating-Room, Wall Vacuum Powered
Med Michigan Holding Llc
SUC-4300S, Rigid Intracardiac Sucker Fluted Tip; 1/4" (6.4mm) connector 13" (33cm) length. Indicated for handheld use only to remove excess fluid from the surgical field.
| Date | Dec 31, 2024 (initiated Nov 19, 2024) |
| Status | Open, Classified |
| Reason | Incomplete or partial pouch seals, which may result in a breach in the sterility. |
| Root cause | Process control |
| Action | On November 19, the firm notified customers via URGENT PRODUCT RECALL NOTICE letters. Customers were provided with an RGA number and instructions to return affected product to the firm as soon as possible. If you have any questions about this recall communication, please contact Lindsey Allende lallende@medalliancegroup.com. |
| Quantity | 109 boxes (2,180 eaches) |
| Distribution | Product distributed to a distributor located in IL. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K971022 | CHASE SUCKER Chase Medical, Inc., Apr 17, 1997 |