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U.S. Department of Health and Human Services

Class 2 Device Recall Major Vascular CDS

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  Class 2 Device Recall Major Vascular CDS see related information
Date Initiated by Firm October 27, 2021
Create Date December 10, 2021
Recall Status1 Terminated 3 on April 05, 2023
Recall Number Z-0360-2022
Recall Event ID 88963
Product Classification General surgery tray - Product Code LRO
Product Major Vascular CDS Convenience Kit
Code Information Model #: CDS981543D Lot #: 19HBK745 UDI: GTIN (01)4088277523976 EXP (17)2021-07-31 LOT (10)19HBK745
Recalling Firm/
Manufacturer		 Medline Industries Inc
3 Lakes Dr
Northfield IL 60093-2753
For Additional Information Contact Kassandra Cotner
866-359-1704
Manufacturer Reason
for Recall		 NaCl 250 mL Bag Inj expired 04/2020 while the kit expiration date was after 04/2020.
FDA Determined
Cause 2		 Incorrect or no expiration date
Action Medline Industries, Inc. is recalling specific convenience kits containing the Baxter NaCl 250mL Bag Inj due to the Baxter NaCl 250mL Bag Inj expiring April 2020. No other components within these packs are affected and can continue to be used. Our records indicate that these Baxter NaCl 250mL Bag Inj were used as a component in the attached list of kit(s) purchased from Medline Industries, Inc. 1. Immediately check your stock for the specific kit number and the affected kit lot number in the attached list. Quarantine any kits with the listed lot numbers. If you don t have any of the lots listed above skip to step 3. 2. Affix the enclosed stickers on the affected kits and return to stock. If additional stickers are needed please call 866-359-1704. Please be sure NOT to use the Baxter NaCl 250mL Bag Inj components, pull another approved product from sterile supply. 3. Please fill out and return the enclosed Verification Form via email to recalls@medline.com or fax 866-767-1290. Note: By signing and returning the Verification Form you acknowledge that you received and understand this notification.
Quantity in Commerce 15
Distribution US Nationwide distribution.
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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