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U.S. Department of Health and Human Services

Class 2 Device Recall Ultrasound Tray

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 Class 2 Device Recall Ultrasound Traysee related information
Date Initiated by FirmAugust 10, 2021
Create DateNovember 18, 2021
Recall Status1 Terminated 3 on June 16, 2023
Recall NumberZ-0255-2022
Recall Event ID 88463
Product Classification Radiology-diagnostic kit - Product Code OIP
ProductREGARD Ultrasound Tray
Code Information Lots numbers: 87414C, 87035C, 86918C, 88755C and 85539C
Recalling Firm/
Manufacturer		 ROi CPS LLC
3000 E Sawyer Rd
Republic MO 65738-2758
For Additional Information ContactLacy Stewart
417-730-3900
Manufacturer Reason
for Recall		Povidone-Iodine swabstick manufactured by PDI, Inc. recalled due to Out of Specifications was used as a component in some of the ROI CPS, LLC products.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionThe correction was sent via e-mail on 08-10-2021 instructing the consignees to removed the Swabsticks (3's) and be discarded at time of use.
Quantity in Commerce240 trays
DistributionUS Nationwide in the states of FL, LA and MO.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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