FDA Recall
Open, Classified
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.
Recall: Z-0796-2025
·
Initiated November 19, 2024
Recall
- Recall Number
- Z-0796-2025
- Event Number
- 95889
- Firm
- Med Michigan Holding Llc
- FEI Number
- 3017540705
- Product Code
- GCX
- Status
- Open, Classified
- Root Cause
- Process control
- Initiated
- November 19, 2024
- Posted
- December 31, 2024
- Address
- 2680 Walker Ave Nw, Ste C, Walker, MI, 49544-1385
Description
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.
Reason
Incomplete or partial pouch seals, which may result in a breach in the sterility.
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 [email protected].
Distribution
Product distributed to a distributor located in IL.
Quantity
109 boxes (2,180 eaches)