—#129440

Product

B.Braun Accuflo 100ML/H 100ML Elastomeric Infusion Device. AccuFlo devices are intended for patients requiring intravenous, percutaneous, subcutaneous, intra-operative sites or epidural administration of medications.

FDA product code: MEB — Pump, Infusion, Elastomeric
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K081905
Affected lot / code info: Lot Number: 4A1125F111

Why it was recalled

The primary packaging label (inner pouch label) indicates that the package contents are Catalog Item: CT-1000-250, while the secondary packaging label (outer carton label) indicates the contents are CT-1000-100. The actual contents are a CT-1000-100.

Root cause (FDA determination)

Labeling Change Control

Action the firm took

B. Braun Medical Inc. provided the recall notification received from B. Braun Melsungen AG to Progressive Medical Inc. who is the initial importer of the product in the U.S. market. The notification was sent via FedEx and e-mail on/about August 6, 2014 and identified the product, problem, and action to be taken. The notification indicated that if the affected units were further distributed that any distributors are required to forward the letter on to their consignees.

Recalling firm

Firm: B. Braun Medical, Inc.
Address: 901 Marcon Blvd, Allentown, Pennsylvania 18109-9512

Distribution

Distribution pattern: Distributed in the state of Missouri.

Timeline

Recall initiated: 2014-08-06
Posted by FDA: 2014-09-16
Terminated: 2015-01-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #129440. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.