Atlas FDA

Zinnanti Injector - 2.0; Size 2.0 mm, Length 23 cm, latex free, single-use, sterile. For in-office or hospital use when

FDA device recall Z-1077-06 · posted 2006-06-01 · Terminated

Recall details

Recalling firm
Catheter Research, Inc
Reason for recall
The uterine stop component was not included with the device.
Action taken
Distributors were notified by letter dated 4/24/06 and requested to notify their customers to return the product.
Root cause
Other
Status
Terminated
Product code
LKF
Quantity affected
660
Distribution
Minnesota and Spain.
Date initiated
2006-04-24
Date posted
2006-06-01
Date terminated
2007-12-04
Location
Indianapolis, IN

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Related 510(k) clearances

RecordFirmDate
UTERINE INJECTOR (K020292)Catheter Research, Inc.2002-04-17