EVLP Convenience Pack/Kit recallZ-0358-2022 · Medline Industries Inc · initiated Oct 27, 2021
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Medline Industries Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
NaCl 250 mL Bag Inj expired 04/2020 while the kit expiration date was after 04/2020.
FDA root cause category: Incorrect or no expiration date
What the company is doing
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.
Recall details
- Recall number
- Z-0358-2022
- Status
- Terminated
- Initiated by the company
- Oct 27, 2021
- Recalling firm
- Medline Industries Inc
- Quantity
- 28
- Product code
- LRO
- Distribution
- US Nationwide distribution.
Product description
EVLP Convenience Pack/Kit
Code information (models, lots, serial numbers)
Model #: DYNJ901205C Lot #: 19HBE998 UDI: GTIN (01)40889942580607 EXP (17)2021-01-31 LOT (10)19HBE998
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Medline Industries, Inc. DYNJ901205CMedline Industries, Inc. · General surgery tray1 recall2 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 88963).
- Z-0359-2022 · TerminatedNeuro Convenience Kit
- Z-0361-2022 · TerminatedVenous Access Pack-LF Convenience Kit
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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