IV KIT - SORBAVIEW IVS3475
FDA Recall Z-0104-2020 · Posted None
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Recalling FirmCenturion Medical Products Corporation
Recall StatusTerminated
Product CodeLRS
Date Initiated2019-04-24
Date Terminated2020-04-03
Product Quantity181965 total
Reason for Recall
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.
Firm Action
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
Root Cause
Under Investigation by firm
Distribution Pattern
Nationwide domestic distribution.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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