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Aspira Drainage Kit

Bard Access Systems, Inc. · Model 4992301 · UDI-DI 00801741045035

FJS Prescription
10
510(k) clearances
2,355
Adverse events (46 deaths)
8
Recalls
26
Facilities

Description

Aspira Pleural/Peritoneal Drainage Kit

Recalls

DateFirmReason
2023-02-15Merit Medical Systems, Inc.Product that was built for design verification testing was inadvertently distributed to customers.
2017-12-20Merit Medical Systems, Inc.Mix-up between adult and pediatrics PD catheter.
2017-09-20Merit Medical Systems, Inc.2 Cuff catheters were incorrectly configured and labeled as 1 Cuff product.
2014-10-20Pfm Medical IncPFM Medical is recalling catheters and other medical devices because they may exceed USP limits for bacterial endotoxin.
2011-05-21Bard Access SystemsLabeling for drainage kit contained incomplete information.
2011-05-21Bard Access SystemsLabeling for drainage kit contained incomplete information.
2011-05-21Bard Access SystemsLabeling for drainage kit contained incomplete information.
2011-05-21Bard Access SystemsLabeling for drainage kit contained incomplete information.

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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.