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Medisystems OneSite dual lumen needle with masterguard
MEDISYSTEMS CORPORATION · Model DL-1214MGE · UDI-DI 00842289100749
FIE
Prescription
10
510(k) clearances
761
Adverse events (49 deaths)
7
Recalls
18
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2012-12-20 | Medisystems a NX Stage Company | Single needle packs in each case ( 10 needles per case) are mislabeled on the pouch as 15 Gauge needles instead of 17 Gauge |
| 2012-12-20 | Medisystems a NX Stage Company | A total of 5 (ea) single needle pouches are mislabeled as 15 Ga x1" instead of 15 Ga x 3/5". |
| 2012-01-31 | Medisystems Corp | Mislabeled outer carton: Outside shipping cartons is stamped 15Ga x 1", product contained within properly labeled as 17Ga x 1" needle |
| 2004-12-03 | HK Surgical Inc | Risk of hubs becoming disconnected from the cannula. |
| 2004-12-03 | HK Surgical Inc | Risk of hubs becoming disconnected from the cannula. |
| 2004-12-03 | HK Surgical Inc | Risk of hubs becoming disconnected from the cannula. |
| 2002-11-08 | Nipro Corp | Air or fluid leakage at the hub/needle junction. |
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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.