Atlas FDA

RYM-5000 InVision-Plus NEUTRAL I.V. Connector, packaged 200 units per box, 5 boxes per case (1000 units/case); labeled a

FDA device recall Z-0320-2007 · posted 2006-12-30 · Terminated

Recall details

Recalling firm
Rymed Technologies, Inc.
Reason for recall
Weld failures on IV connector (area of female luer and spike body)
Action taken
Consignees were notified by e-mail and/or phone on 05/25/06 regarding the recall. Distributors were asked to return product.
Root cause
Other
Status
Terminated
Product code
FPA
Quantity affected
16,000 units.
Distribution
Nationwide Recall
Date initiated
2006-05-25
Date posted
2006-12-30
Date terminated
2007-03-26
Location
Austin, TX

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Related 510(k) clearances

RecordFirmDate
INVISION-PLUS INJECTION PORT CONNECTOR SYSTEM (K991653)Rymed Technologies, Inc.1999-06-24