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
Product summary
- 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
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.