Recall Z-0360-2022

Medline Industries Inc · initiated October 27, 2021

Class II Terminated

Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature

Product

Major Vascular CDS Convenience Kit

Codes / lots: Model #: CDS981543D Lot #: 19HBK745 UDI: GTIN (01)4088277523976 EXP (17)2021-07-31 LOT (10)19HBK745

Reason for recall

NaCl 250 mL Bag Inj expired 04/2020 while the kit expiration date was after 04/2020.

FDA-determined cause: Incorrect or no expiration date

Action taken

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.

Details

Recall number
Z-0360-2022
Initiated
October 27, 2021
Terminated
April 5, 2023
Product code
LRO – General Surgery Tray
Quantity
15
Distribution
US Nationwide distribution.
Recalling firm
Medline Industries Inc, Northfield, IL

Official FDA recall record

Other products in the same recall event

RecallProductInitiated
Z-0358-2022 Class IIEVLP Convenience Pack/KitNaCl 250 mL Bag Inj expired 04/2020 while the kit expiration date was after 04/2020. 10/27/2021Terminated
Z-0359-2022 Class IINeuro Convenience KitNaCl 250 mL Bag Inj expired 04/2020 while the kit expiration date was after 04/2020. 10/27/2021Terminated
Z-0361-2022 Class IIVenous Access Pack-LF Convenience KitNaCl 250 mL Bag Inj expired 04/2020 while the kit expiration date was after 04/2020. 10/27/2021Terminated
Z-0362-2022 Class IIBedside PICC CDS Convenience KitNaCl 250 mL Bag Inj expired 04/2020 while the kit expiration date was after 04/2020. 10/27/2021Terminated