Nonsterile convenience kits: (1) regard Item #830099008, CV01005H - CV Part 1 Bundle; and (2) regard Item #830019017, CV

FDA device recall Z-1407-2022 · posted 2022-07-19 · Terminated

Recall details

Recalling firm

ROi CPS LLC

Reason for recall

Some nonsterile components that were supposed to be sterile were packaged in nonsterile kits.

Action taken

The recalling firm initiated the recall via telephone on 6/3/2022 to the direct consignee of Item 830019017, explained the reason for recall, and instructed the product be quarantined. The recalling firm also contacted the end user who had received distribution from the direct consignee. The end user was informed of the error and was requested to remove the affected lot from their inventory. The recalling firm worked with the end user to have the kits returned to the direct consignee where they were placed in quarantine. Regarding the recall of Item #830099008 and Item #830014016, the direct consignees were notified on 6/6/2022 via telephone requesting the affected kits be placed on hold and moved to a quarantined area. A follow-up email was sent to the recall coordinator for the direct consignees (which was the same recall coordinator) on 6/16/2022 which contained a correction notice. The email explained the issue and said the recalling firm has already performed rework on the kits in the inventory at their location (the two direct consignee locations) so no additional actions were required except for the completion of the reply form to indicate receipt of the notice. The attached Medical Device Correction Notice was dated 6/16/2022 and explained the issue, the affected product, the health risk assessment, and the actions taken by the recalling firm, which included rework of the products that had been returned to the direct consignees. The enclosed replay form was to be completed acknowledging the consignee has read and understands the notice.

Root cause

Process change control

Status

Terminated

Product code

OEZ

Quantity affected

86 kits

Distribution

Distribution was made to MO. There was no foreign/military/government distribution.

Date initiated

2022-06-03

Date posted

2022-07-19

Date terminated

2023-04-14

Location

Republic, MO