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Haemonetics
HAEMONETICS CORPORATION · Model PL1B · UDI-DI 10887691000116
CAK
Prescription
10
510(k) clearances
1,660
Adverse events (7 deaths)
1
Recalls
14
Facilities
Description
PL High efficiency Leukocyte Reduction Filter for a Single Unit of Platelet Concentrate with Attached 175 mL PVC Transfer bag with Needleless Injection Port
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-11-03 | GVS TM, Inc | Due to products being released for distribution prior to completion of the required quality control release process the sterility assurance cannot be confirmed. |
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Get your free API keyRead the docsData 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.