SUC-4300S, Rigid Intracardiac Sucker Fluted Tip; 1/4" (6.4mm) connector 13" (33cm) length. Indicated for handheld use on
FDA device recall Z-0796-2025 · posted 2024-12-31 · Open, Classified
Recall details
- Recalling firm
- Med Michigan Holding Llc
- Reason for recall
- Incomplete or partial pouch seals, which may result in a breach in the sterility.
- Action taken
- 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.
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- GCX
- Quantity affected
- 109 boxes (2,180 eaches)
- Distribution
- Product distributed to a distributor located in IL.
- Date initiated
- 2024-11-19
- Date posted
- 2024-12-31
- Location
- Walker, MI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CHASE SUCKER (K971022) | Chase Medical, Inc. | 1997-04-17 |