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.
This recall is currently active, issued December 31, 2024. It was issued by Med Michigan Holding Llc.
- Company
- Med Michigan Holding Llc
- Recall Initiated
- November 19, 2024
- Posted
- December 31, 2024
- Recall Number
- Z-0796-2025
- Quantity
- 109 boxes (2,180 eaches)
- Firm Location
- Walker, MI
- Official Source
- View on FDA website ↗
Reason for Recall
Incomplete or partial pouch seals, which may result in a breach in the sterility.
Distribution
Product distributed to a distributor located in IL.
Lot / Code Info
UDI-DI 00817278010514 Lot 08294-080724
Root Cause
Process control
Action Taken
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.