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U.S. Department of Health and Human Services

Class 2 Device Recall Regard

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 Class 2 Device Recall Regardsee related information
Date Initiated by FirmOctober 12, 2020
Date PostedDecember 02, 2020
Recall Status1 Terminated 3 on May 13, 2021
Recall NumberZ-0524-2021
Recall Event ID 86626
Product Classification Labor and Delivery Kit - Product Code MLS
ProductRegard - Product Usage: Obstetric Gynecologic specialized manual instrument. Labor and delivery kits.
Code Information Lot Numbers: 78483C, 79932C, 81043C, 82586C, 83090C. 
Recalling Firm/
Manufacturer		 ROi CPS LLC
3000 E Sawyer Rd
Republic MO 65738-2758
For Additional Information ContactCheyenne L. Stewart
417-730-3900
Manufacturer Reason
for Recall		Labeling error, incorrect expiration date.
FDA Determined
Cause 2		Labeling Change Control
ActionROi CPS, LLC issued the recall in the form of customer notices sent through email on 10/12 2020. The customer recall notices required that the consignees review their inventory and segregate the affected kits, so a correction of affected kits can be coordinated . Kits reported to ROi CPS, LLC will be reworked to correct the labeling on each kit prior to releasing back to the consignees. ROi CPS, LLC requested that consignees forward the recall notice to any other users who may have received the affected kits. As of the date of this letter, no product has been returned to ROi CPS, LLC, we will continue to monitor responses from the distribution center and the end user. Kits that are reported will be quarantined and then reworked to correct the labeling prior to releasing back to the end user.
Quantity in Commerce220 kits
DistributionUS Nationwide distribution in the states of MO and OK.
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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