—#178532

Product

Centurion Neonatal PICC Tray: CVI2310 NEONATAL PICC INSERTION TRAY CVI2550 NEONATAL PICC INSERTION TRAY CVI2550 NEONATAL PICC INSERTION TRAY CVI2550 NEONATAL PICC INSERTION TRAY CVI2550 NEONATAL PICC INSERTION TRAY CVI3650 PEDS PICC INSERTION TRAY CVI3730 NEONATAL PICC LINE TRAY CVI4235 NEONATAL PROCEDURE PICC TRAY CVI4395A NICU PICC INSERTION KIT CVI4395A NICU PICC INSERTION KIT CVI4565 NEONATAL PICC TRAY

FDA product code: OFF — Central Venous Catheter Tray
Device class: Class 2
Medical specialty: Cardiovascular
Affected lot / code info: Kit Code Product Lot Number CVI2310 NEONATAL PICC INSERTION TRAY 2018122190 CVI2550 NEONATAL PICC INSERTION TRAY 2019061190 CVI2550 NEONATAL PICC INSERTION TRAY 2019020190 CVI2550 NEONATAL PICC INSERTION TRAY 2019010490 CVI2550 NEONATAL PICC INSERTION TRAY 2018101190

Why it was recalled

Incomplete seals on the sterile package may compromise the sterility

Root cause (FDA determination)

Packaging process control

Action the firm took

Centurion issued a notification emailed to Medline Industries, Centurion's parent company. Centurion issued mailing letters via First Class Mail beginning on 12/12/2019, letter states reason for recall, health risk and action to take: Please identify all inventory that you have within your possession and segregate it in a location where it cannot be accessed for use. 2) If you have transferred possession of this product to another individual, to another department or to another location in your organization, you are required by FDA regulations to notify them of this recall communication. Please ask that any affected product be returned to you for collection. 3) Affected product is not to be returned to Centurion, and should be destroyed/discarded. Document the destruction of all product on the enclosed accountability record. 4) Please complete the enclosed accountability record, whether or not you have product, and fax or email at your earliest convenience to the attention of Lisa Carpenter, Director of Quality Assurance Centurion Medical Products Corporation, (517) 546-5400 Ext.1122.

Recalling firm

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

Distribution

Distribution pattern: Nationwide Foreign: GHANA

Timeline

Recall initiated: 2019-12-11
Terminated: 2020-09-04
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #178532. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.