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Recall Observatory FDA recall evidence

Device product

B. Braun AccuFlo Elastomeric Infusion Pump 200ML/H 100 ML Generally used for delivery of antibiotic and local anesthesia medications.

Z-0921-2014

December 13, 2013

Class II

Product summary

Firm
B. Braun Medical, Inc.
Event
Event 67172
Status
Terminated
Classification
Class II
Quantity
30, 240 units
Official record key
device-enforcement:Z-0921-2014

Official wording

Reason: Internal testing of two lots of the AccuFlo CT-2000-100 Elastomeric Infusion Pump identified flow rates which are outside the specified infusion time and may result in overly rapid infusion of medications.

Code information: Catalog #CT-2000-100lots 3H0125F151 and 3H0225F151, expiration 7/2018.

Distribution pattern: US Distribution one importer/wholesale distributor in MO.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Internal testing of two lots of the AccuFlo CT-2000-100 Elastomeric Infusion Pump identified flow rates which are outside the specified infusion time and may result in overly rapid infusion of medications.