—#124860

Product

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

FDA product code: MEB — Pump, Infusion, Elastomeric
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K081905
Affected lot / code info: Catalog #CT-2000-100lots 3H0125F151 and 3H0225F151, expiration 7/2018.

Why it was recalled

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.

Root cause (FDA determination)

Process design

Action the firm took

B. Braun Medical sent an Urgent Medical Device Recall letter dated December 13, 2013 to affected customer. The letter identified the product the problem and the action needed to be taken by the customer. The letter was sent to Progressive Medical Inc., the Importer and B. Braun's sole customer. WHAT ACTIONS SHOULD I TAKE? 1. Further use and/or distribution of the affected product should be discontinued immediately. Please identify and quarantine any impacted materials in your possession. 2. Review this recall notification in its entirety and ensure that all users within your organization and any consignees your organization may have are informed of this recall. If you are a distributor, please forward this recall notice to any customers who are in receipt of the impacted product. 3. Determine your current inventory of the affected lots within your facility. Do not destroy any affected product. 4. Utilizing the attached "Recall Acknowledgement" form record the number of full cases and individual units (for any loose units or partial cases) in your possession. If you have no inventory, please indicate that you have zero (0) inventory on the "Recall Acknowledgement" form. 5. Return the completed "Recall Acknowledgement" form to B. Braun Medical Inc. Quality Assurance who will administer the recall on behalf of B. Braun Melsungen AG. The form must be e-mailed to PA_QualityAssurance.BBMUS.Service@bbraun.com or faxed to (610) 849-1197 within two (2) weeks of receipt even it the inventory in your possession is zero. 6. Instructions for Credit, Replacement, Et Return: a.If you have purchased the product from a third-party and have any full cases, partial cases, or unused individual pieces in your possession please contact the seller to obtain instructions for handling these units. b.If you have purchased the product directly from B. Braun Medical Inc. and have any full cases, partial cases, or unused individual pieces of these affected products, ple

Recalling firm

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

Distribution

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

Timeline

Recall initiated: 2013-12-13
Posted by FDA: 2014-02-03
Terminated: 2014-09-03
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #124860. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.