Recalls / —

—#175682

Product

Maintenance Flush Kit/Blood Draw Product Code: DT19335

FDA product code

OIB — Blood And Urine Collection Kit (Excludes Hiv Testing)

Device class

Class 1

Medical specialty

Pathology

Affected lot / code info

Lot Number Expiration 2018110501 7/31/2021 2018121801 7/31/2021 2019013001 9/30/2021 2019032901 9/30/2021

Why it was recalled

Supplier initiated recall of the GRIPPER Needles

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

1. Please identify all inventory that you have within your possession and cease use immediately. 2. 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. Upon receipt of this record, Centurion Representative will contact you regarding retrieval of the product from your facility. 3. Please forward this recall information to any facilities to who this product may have been further distributed, instructing them to cease use immediately.

Recalling firm

Firm

Centurion Medical Products Corporation

Address

100 Centurion Way, Williamston, Michigan 48895-9086

Distribution

Distribution pattern

IL

Timeline

Recall initiated

2019-07-15

Terminated

2020-08-31

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #175682. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.