CLASS II Device recall · Reported 22 Dec 2021 · FDA Enforcement Report

EVLP Convenience Pack/Kit recalled by Medline Industries

Medline Industries is recalling EVLP Convenience Pack/Kit, distributed nationwide in the US. The recall was initiated on 27 Oct 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel #: DYNJ901205C Lot #: 19HBE998 UDI: GTIN (01)40889942580607 EXP (17)2021-01-31 LOT (10)19HBE998
Quantity recalled28

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number
Z-0358-2022
FDA event ID
88963
Recalling firm
Medline Industries, Northfield, IL
Classification
Class II
Status
Terminated
Recall initiated
27 Oct 2021
FDA classified
10 Dec 2021
Reported
22 Dec 2021
Type
Voluntary: Firm initiated
Customers notified by
E-Mail
Reason category
Other Reasons

Timeline

27 Oct 2021Recall initiated by company
10 Dec 2021Classified by FDA+44 days
22 Dec 2021Published in enforcement report+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

EVLP Convenience Pack/Kit

Where it was distributed

US Nationwide distribution.

Nationwide

Questions about this recall

Is EVLP Convenience Pack/Kit recalled?

Yes. Medline Industries recalled EVLP Convenience Pack/Kit on 27 Oct 2021. The recall is Class II and its status is Terminated. Recall number Z-0358-2022.

Why was it recalled?

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

Which lots are affected?

Model #: DYNJ901205C Lot #: 19HBE998 UDI: GTIN (01)40889942580607 EXP (17)2021-01-31 LOT (10)19HBE998

Where was it sold?

US Nationwide distribution.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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