Atlas FDA

Horizon Pump Metriset Burette Set. The product is shipped in cases containing 20 sets.

FDA device recall Z-0819-2007 · posted 2007-05-31 · Terminated

Recall details

Recalling firm
B. Braun Medical, Inc.
Reason for recall
Secondary infusion backs up into primary container.
Action taken
The recalling firm issued Product Removal Notices on 4/20/07 via certified priority mail. The notice informed the customer of the problem and the need to return the product.
Root cause
Other
Status
Terminated
Product code
FPA
Quantity affected
2.5 million for all products
Distribution
Nationwide and Canada.
Date initiated
2007-04-18
Date posted
2007-05-31
Date terminated
2008-04-22
Location
Allentown, PA

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Recalls and clearances share one API, with change alerts when new recalls post.

Related 510(k) clearances

RecordFirmDate
V2 INJECTION SITE (K955585)B.Braun Medical, Inc.1996-05-15
VOLUMETRIC INFUSION PUMP (K904518)Kendall Mcgaw Laboratories, Inc.1990-10-17