Recalls / —

—#190149

Product

EVLP Convenience Pack/Kit

FDA product code: LRO — General Surgery Tray
Device class: Class 2
Medical specialty: General, Plastic Surgery
Affected lot / code info: Model #: DYNJ901205C Lot #: 19HBE998 UDI: GTIN (01)40889942580607 EXP (17)2021-01-31 LOT (10)19HBE998

Why it was recalled

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

Root cause (FDA determination)

Incorrect or no expiration date

Action the firm took

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.

Recalling firm

Firm: Medline Industries Inc
Address: 3 Lakes Dr, Northfield, Illinois 60093-2753

Distribution

Distribution pattern: US Nationwide distribution.

Timeline

Recall initiated: 2021-10-27
Terminated: 2023-04-05
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #190149. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.