Rigid Intracardiac Sucker Units Recalled for Potential Sterility Breach
Med Michigan Holding recalls SUC-4300S Rigid Intracardiac Suckers due to incomplete or partial pouch seals that may compromise sterility during cardiac surgery.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall with no reported hospitalizations, injuries, or deaths. The hazard—incomplete pouch seals creating a potential sterility breach—represents a risk of harm to surgical patients, but no actual infections or adverse events have been reported.
Plain-English summary
Med Michigan Holding Llc is recalling the SUC-4300S Rigid Intracardiac Sucker Fluted Tip, a surgical instrument used during cardiac procedures. The device features a 1/4-inch (6.4mm) connector and 13-inch (33cm) length and is designed for handheld use to remove excess fluid from the surgical field.
The recall addresses incomplete or partial pouch seals on the product packaging that may result in a breach of sterility. Compromised sterility could expose patients to contamination during surgical procedures.
Approximately 2,180 units in 109 boxes with lot number 08294-080724 were distributed to a medical device distributor in Illinois. The affected product can be identified by UDI-DI 00817278010514.
Healthcare facilities should immediately identify and discontinue use of any affected units. Contact Med Michigan Holding Llc or the distributor for return instructions and replacement stock.
The recalled product
- Product
- 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.
- Manufacturer
- Med Michigan Holding Llc
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI-DI 00817278010514 Lot 08294-080724
Distribution
Distributed in 1 state:
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