Recalls / —

—#175683

Product

Kit, Port Access Product Code: DYNDC1582A

FDA product code

LRO — General Surgery Tray

Device class

Class 2

Medical specialty

General, Plastic Surgery

Affected lot / code info

Lot Number Expiration 2018121350 8/31/2020 2019020750 9/30/2020 2019031550 4/30/2021 2019041550 4/30/2021 2019061750 1/31/2021 2019062450 4/30/2021

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 #175683. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.