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.
Reported: January 8, 2025 Initiated: November 19, 2024 #Z-0796-2025
Product Description
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.
Reason for Recall
Incomplete or partial pouch seals, which may result in a breach in the sterility.
Details
- Recalling Firm
- Med Michigan Holding Llc
- Units Affected
- 109 boxes (2,180 eaches)
- Distribution
- Product distributed to a distributor located in IL.
- Location
- Walker, MI
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Med Michigan Holding Llc. Units affected: 109 boxes (2,180 eaches).
Why was this product recalled? ▼
Incomplete or partial pouch seals, which may result in a breach in the sterility.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 8, 2025. Severity: Moderate. Recall number: Z-0796-2025.
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