Recall Z-0095-2020
Centurion Medical Products Corporation · initiated April 24, 2019
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
CVC TRIPLE LUMEN SAFETY BUNDLE ECVC6070
Codes / lots: 2018081550 2018091750 2018100850
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.
FDA-determined cause: Under Investigation by firm
Action taken
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
Details
- Recall number
- Z-0095-2020
- Initiated
- April 24, 2019
- Terminated
- April 3, 2020
- Product code
- OES – Cardiac Catheterization Kit
- Quantity
- 181965 total
- Distribution
- Nationwide domestic distribution.
- Recalling firm
- Centurion Medical Products Corporation, Williamston, MI
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0075-2020 Class II | PICC Line Accessory Kit CVI4285Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the… | 04/24/2019Terminated |
| Z-0076-2020 Class II | PEDIATRIC PICC INSERTION TRAY CVI4450Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the… | 04/24/2019Terminated |
| Z-0077-2020 Class II | PEDIATRIC PICC INSERTION TRAY CVI4450AFirm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the… | 04/24/2019Terminated |
| Z-0078-2020 Class II | NEONATAL PROCEDURE TRAY PICC CATHETERS CVI4535Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the… | 04/24/2019Terminated |
| Z-0079-2020 Class II | CVC BUNDLE WITHOUT CATH CVI4600Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the… | 04/24/2019Terminated |
| Z-0080-2020 Class II | PORT AND IO ACCESS DRESSING KIT DT15780AFirm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the… | 04/24/2019Terminated |
| Z-0081-2020 Class II | Cap Change Kit DT20310Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the… | 04/24/2019Terminated |
| Z-0082-2020 Class II | Neonatal Cap Change Kit DT20315Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the… | 04/24/2019Terminated |
| Z-0083-2020 Class II | CAP CHANGE KIT DYNDC1496BFirm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the… | 04/24/2019Terminated |
| Z-0084-2020 Class II | INFUSA PORT KIT DYNDC1840EFirm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the… | 04/24/2019Terminated |
| Z-0085-2020 Class II | INFUSA PORT KIT DYNDC1840FFirm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the… | 04/24/2019Terminated |
| Z-0086-2020 Class II | STERILE CAP CHANGE KIT DYNDC1946BFirm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the… | 04/24/2019Terminated |
| Z-0087-2020 Class II | CAP BUNDLE KIT DYNDC2137Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the… | 04/24/2019Terminated |
| Z-0088-2020 Class II | TRIPLE LUMEN BUNDLE KIT ECVC1540Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the… | 04/24/2019Terminated |
| Z-0089-2020 Class II | CENTRAL VENOUS ACCESS DEVICE BUNDLE ECVC2840Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the… | 04/24/2019Terminated |
| Z-0090-2020 Class II | CVC BUNDLE, 20CM, 4L, PI ECVC5095Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the… | 04/24/2019Terminated |
| Z-0091-2020 Class II | CVC BUNDLE, 20CM, 3L, PI ECVC5120Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the… | 04/24/2019Terminated |
| Z-0092-2020 Class II | CVC BUNDLE, 20CM, 3L, PI ECVC5120AFirm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the… | 04/24/2019Terminated |
| Z-0093-2020 Class II | CVC BUNDLE MULTIMED, 3L, 20CM ECVC6060Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the… | 04/24/2019Terminated |
| Z-0094-2020 Class II | CVC BUNDLE VANTEX 7F, 3L, 20CM ECVC6065Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the… | 04/24/2019Terminated |
| Z-0096-2020 Class II | CVC INSERTION BUNDLE 8.5FR 4L 16CM ECVC6355Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the… | 04/24/2019Terminated |
| Z-0097-2020 Class II | CENTRAL LINE BUNDLE ECVC6375Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the… | 04/24/2019Terminated |
| Z-0098-2020 Class II | CENTRAL LINE BUNDLE 16CM MULTIMED ECVC6545Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the… | 04/24/2019Terminated |
| Z-0099-2020 Class II | CENTRAL LINE BUNDLE 16CM MULTIMED ECVC6545AFirm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the… | 04/24/2019Terminated |
| Z-0100-2020 Class II | OR VANTEX 7FR 3L 16CM CVC ECVC6665Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the… | 04/24/2019Terminated |
| Z-0101-2020 Class II | VANTEX 7FR, 16CM, 3L CVC BUNDLE ECVC6670Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the… | 04/24/2019Terminated |
| Z-0102-2020 Class II | IV START KIT IV8440Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the… | 04/24/2019Terminated |
| Z-0103-2020 Class II | IV SECUREMENT KIT IVS3405Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the… | 04/24/2019Terminated |
| Z-0104-2020 Class II | IV KIT - SORBAVIEW IVS3475Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the… | 04/24/2019Terminated |
| Z-0105-2020 Class II | INVASIVE PROCEDURE TRAY MNS9510Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the… | 04/24/2019Terminated |