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Terminated

Venous Access Pack-LF Convenience Kit

FDA Recall Z-0361-2022 · Posted None

Recalling FirmMedline Industries Inc
Recall StatusTerminated
Product CodeOFF
Date Initiated2021-10-27
Date Terminated2023-04-05
Product Quantity15

Reason for Recall

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

Firm 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 [email protected] or fax 866-767-1290. Note: By signing and returning the Verification Form you acknowledge that you received and understand this notification.

Root Cause

Incorrect or no expiration date

Distribution Pattern

US Nationwide distribution.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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