—#176282

Product

CVC BUNDLE, 20CM, 3L, PI ECVC5120A

FDA product code: OES — Cardiac Catheterization Kit
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K171957
Affected lot / code info: 2018032350 2018081050 2018091950 2018112750 2018121850 2019012450 2019013050

Why it was recalled

Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the connector following disconnection.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

On April 24, 2019, the firm notified customers who had received kits containing BD's MaxZero product. Customers were instructed to do the following: 1. Whether or not you have product in inventory, please complete and return the attached Centurion Accountability Record via email- lcarpenter@centurionmp.com or via fax-517-546-3356. 2. Please share this communication with all users of the product within your organization, as directed in the BD letter. 3. Report any adverse health consequences experienced with the use of this product to BD. Events may also be reported to the FDA's MedWatch Adverse Event Reporting program. Web: MedWatch website at www.fda.gov/medwatch Phone: 1-800-FDA-1088 (1- 800-332-1088); Mail: MedWatch, HF-2, FDA, 5600 Fisher's Lane, Rockville, MD 20852- 9787

Recalling firm

Firm: Centurion Medical Products Corporation
Address: 100 Centurion Way, Williamston, Michigan 48895-9086

Distribution

Distribution pattern: Nationwide domestic distribution.

Timeline

Recall initiated: 2019-04-24
Terminated: 2020-04-03
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #176282. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.