FDA Device Intelligence
Home › HAEMONETICS CORPORATION › Haemonetics

Haemonetics

HAEMONETICS CORPORATION · Model SQ40SK · UDI-DI 10887691000673

CAK Prescription
1
510(k) clearances
1,660
Adverse events (7 deaths)
1
Recalls
14
Facilities

Description

Microaggregate Blood Transfusion Filter with Attached Straight Administration Set with 3 mm Tubing

Recalls

DateFirmReason
2025-11-03GVS TM, IncDue to products being released for distribution prior to completion of the required quality control release process the sterility assurance cannot be confirmed.

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API keyRead the docs
Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.