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NATIONAL HOSPITAL PACKAGING

Surgi-Pak, Inc. · Model 38-048 · UDI-DI 00817213021537

GBN
2
510(k) clearances
1
Adverse events (1 deaths)
1
Recalls
9
Facilities

Description

FLX PVC CATH NA, W/CON, 24IN X 2 EA, 1/PKG, STRL

Recalls

DateFirmReason
2014-10-08Customed, IncCustomed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncont

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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.