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COLLINS SPORTS

Asp Global, LLC · Model CS3534S · UDI-DI 00840216119376

IMA
8
510(k) clearances
49
Adverse events
9
Recalls
87
Facilities

Description

OVERSIZE HOT PAC COVER WITH FOAM, 1/EA

Recalls

DateFirmReason
2024-02-21Bruder Healthcare Company, LLCThermalon and MediBeads moist heat compresses from certain lots may have been exposed to excessive moisture, resulting in potential growth of mold and/or mildew.
2024-02-21Bruder Healthcare Company, LLCThermalon and MediBeads moist heat compresses from certain lots may have been exposed to excessive moisture, resulting in potential growth of mold and/or mildew.
2024-02-21Bruder Healthcare Company, LLCThermalon and MediBeads moist heat compresses from certain lots may have been exposed to excessive moisture, resulting in potential growth of mold and/or mildew.
2024-02-21Bruder Healthcare Company, LLCThermalon and MediBeads moist heat compresses from certain lots may have been exposed to excessive moisture, resulting in potential growth of mold and/or mildew.
2024-02-21Bruder Healthcare Company, LLCThermalon and MediBeads moist heat compresses from certain lots may have been exposed to excessive moisture, resulting in potential growth of mold and/or mildew.
2024-02-21Bruder Healthcare Company, LLCThermalon and MediBeads moist heat compresses from certain lots may have been exposed to excessive moisture, resulting in potential growth of mold and/or mildew.
2024-02-21Bruder Healthcare Company, LLCThermalon and MediBeads moist heat compresses from certain lots may have been exposed to excessive moisture, resulting in potential growth of mold and/or mildew.
2024-02-21Bruder Healthcare Company, LLCThermalon and MediBeads moist heat compresses from certain lots may have been exposed to excessive moisture, resulting in potential growth of mold and/or mildew.
2024-02-21Bruder Healthcare Company, LLCThermalon and MediBeads moist heat compresses from certain lots may have been exposed to excessive moisture, resulting in potential growth of mold and/or mildew.

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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.