FDA Device Intelligence
Home › ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD. › Safedraw™

Safedraw™

ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD. · Model 10884450326432 · UDI-DI 10884450326432

DSK
10
510(k) clearances
546
Adverse events (3 deaths)
1
Recalls
100
Facilities

Recalls

DateFirmReason
2012-05-04Argon Medical Devices, IncSome of the kits may exhibit a potential defect with the pouch seal. The pouch issue may compromise the sterile barrier.

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.