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U.S. Department of Health and Human Services

Class 2 Device Recall Respirator Crash Cart Kit

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  Class 2 Device Recall Respirator Crash Cart Kit see related information
Date Initiated by Firm May 19, 2020
Create Date June 26, 2020
Recall Status1 Terminated 3 on September 01, 2020
Recall Number Z-2466-2020
Recall Event ID 85736
Product Classification Cardiopulmonary resuscitation aid kit - Product Code OEV
Product Respirator Crash Cart Kit
Code Information Item #: 830066; Lot #: 77127, 74813 and 63168 Expiration date per lot: Lot: 77127, Exp date: 1/31/2021 Lot: 74813, Exp date: 8/30/2021 Lot: 63168, Exp date: 1/30/2021
Recalling Firm/
Manufacturer		 ROi CPS LLC
3000 E Sawyer Rd
Republic MO 65738-2758
For Additional Information Contact Cheyenne L. Stewart
417-730-3900
Manufacturer Reason
for Recall		 Roi CPS, LLC has become aware of a labeling error that affects select custom procedure kits. The kits are labeled with an expiration date that is later than that of the soonest kit component to expire in the kits.
FDA Determined
Cause 2		 Error in labeling
Action On May 19, 2020 Roi CPS LLC notified its customers to review their inventory to determine if the custom procedure kit item and lot identified were on their inventory. If identified, please quarantine and notify Roi of the quantity on hand completing the reply form provided to them via email and to forward this notification to all potential user of the recall.
Quantity in Commerce 200 kits
Distribution Domestic distribution only to: MO and LA.
Total Product Life Cycle TPLC 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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