regard Item Number: 800774001, CV00979A - CV Minor Kit, Sterile.

FDA device recall Z-1295-2022 · posted 2022-06-28 · Terminated

Recall details

Recalling firm

ROi CPS LLC

Reason for recall

A nonsterile component was packaged in a sterile convenience kit.

Action taken

The recalling firm called the consignee on 5/20/2022 to discuss the recall, including quarantine of affected product, customer fulfilment/available inventory, end user facility notification, recall timelines, and establishing a plan for relabeling by the recalling firm personnel at the distribution center. The recalling firm issued an email to the consignee on 5/20/2022 with an attached recall notice that was previously discussed with the consignee. The email requested the consignee to quarantine the kits and immediately notify the end user facilities who have been shipped the affected kits. In the email, the recalling firm reported they would be sending someone to the direct account and to the end user facilities to complete the correction of the affected kits. The attached letter dated 5/20/22 informed the customer of the reason for recall, health risk assessment, and the actions to be taken by customers. The letter contained a picture of the non-sterile Ultrasound Gel that is to be discarded from the kits. A Recall Reply Form was enclosed to indicate the quantity of product in the customer's possession. The customer was also supposed to indicate that they have read and understand the notice and it has been forwarded to all customers who have been shipped the affected product.

Root cause

Process change control

Status

Terminated

Product code

OEZ

Quantity affected

180 kits

Distribution

US Nationwide distribution in the state of FL.

Date initiated

2022-05-20

Date posted

2022-06-28

Date terminated

2023-05-02

Location

Republic, MO