Regard Dressing change kit, Item Number 800026006

FDA device recall Z-0596-2024 · posted 2024-01-03 · Terminated

Recall details

Recalling firm

ROi CPS LLC

Reason for recall

ROi CPS manufactured and distributed medical convenience kits with an irrigation solution component which was subsequently recalled by the component manufacturer.

Action taken

ROi CPS issued an URGENT MEDICAL DEVICE CORRECTION NOTICE to its sole consignee on 11/27/2023 via email. The notice explained the problem, potential risk, and requested the following actions: 1. CHECK: Please review your inventory to determine if the manufacturer item number and lot numbers listed in the above table are in your inventory. 2. QUARANTINE: Segregate and quarantine all affected kits listed above. Do not further distribute. 3. REMOVE: The affected Cardinal Health item 1022-(100ML Sterile Saline Irrigation bottle), attached to the outside of the affected kits as a piggy back prior to use or further distribution. The remainder of the kit is not affected and can be distributed/used after the 100 ML Saline Irrigation Bottle is removed. 4. REPLY: Please indicate your understanding and completion of the instructions above by completing and returning the attached reply form. a. Complete the section confirming destruction of the sterile saline irrigation bottles removed from the outside of the kit, if applicable, and discard according to your institution's disposal procedures. b. Complete and return the reply form even if you do not have any affected inventory at your facility to acknowledge receipt of the notices. c. Please return the reply form to lacy.stewart@roiscs.com. 5. NOTIFY: Please immediately notify any customers to whom you have distributed or forwarded product affected by this medical device correction notice. You may include a copy of this notice, the notice from Cardinal Health, and the initial recall issued by Nurse Assist in your communication. 6. END USERS: End user facilities are to follow the instructions above and complete and return the reply form indicating their understanding and compliance with the required actions, including the destruction of the Sterile Saline Irrigation Bottles.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

OXQ

Quantity affected

1830 units

Distribution

US Nationwide distribution in the state of Louisiana.

Date initiated

2023-11-20

Date posted

2024-01-03

Date terminated

2024-08-05

Location

Republic, MO