Intracardiac Sucker (Med Michigan) – Pouch Seal Defect (2024)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Med Michigan Holding Llc
Lot Codes / Batch Numbers
UDI-DI 00817278010514 Lot 08294-080724
Products Sold
UDI-DI 00817278010514 Lot 08294-080724
Med Michigan Holding Llc is recalling SUC-4300S, Rigid Intracardiac Sucker Fluted Tip; 1/4" (6.4mm) connector 13" (33cm) length. Indicated due to Incomplete or partial pouch seals, which may result in a breach in the sterility.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Incomplete or partial pouch seals, which may result in a breach in the sterility.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
IL, IN
Page updated: Jan 10, 2026