SUC-4300S recall: Sterility Concern
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…
Why was SUC-4300S recalled?
Incomplete or partial pouch seals, which may result in a breach in the sterility.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI-DI 00817278010514 Lot 08294-080724
- 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…
- Recalling firm
- Med Michigan Holding Llc
- Quantity
- 109 boxes (2,180 eaches)
- Distribution
- Product distributed to a distributor located in IL.
- Recall date
- January 8, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)