PORT AND IO ACCESS DRESSING KIT DT15780A
Recall
- Recall Number
- Z-0080-2020
- Event Number
- 83584
- Firm
- Centurion Medical Products Corporation
- FEI Number
- 3008403546
- Product Code
- OXQ
- Status
- Terminated
- Root Cause
- Under Investigation by firm
- Initiated
- April 24, 2019
- Terminated
- April 3, 2020
- Address
- 100 Centurion Way, Williamston, MI, 48895-9086
Description
PORT AND IO ACCESS DRESSING KIT DT15780A
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.
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- [email protected] 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
Nationwide domestic distribution.
181965 total