FDA Medical Device Recalls (openFDA)
Med Michigan Holding Llc: 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 number
- Z-0796-2025
- Recalling firm
- Med Michigan Holding Llc
- 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.
- Status
- Open, Classified
- Initiated
- 2024-11-19
- Posted
- 2024-12-31
- Terminated
- not on file
- Reason
- Incomplete or partial pouch seals, which may result in a breach in the sterility.
- Root cause
- Process control
- 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 lallende@medalliancegroup.com.
- Quantity
- 109 boxes (2,180 eaches)
- Distribution
- Product distributed to a distributor located in IL.
- Lot, serial or model codes
- UDI-DI 00817278010514 Lot 08294-080724
- 510(k) numbers
- ["K971022"]
- PMA numbers
- not on file
- Product code
- GCX
- Firm FEI
- 3017540705
- Firm city
- Walker
- Firm state
- MI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28