Summary
The FDA issued a Class II for EVLP Convenience Pack/Kit by Medline Industries Inc. Reason: NaCl 250 mL Bag Inj expired 04/2020 while the kit expiration date was after 04/2020..
Details
Source
Device Recall
External ID
Z-0358-2022
Action Date
2021-12-22
Status
Terminated
Category
device
Product Description
EVLP Convenience Pack/Kit
Lot/Code Info: Model #: DYNJ901205C Lot #: 19HBE998 UDI: GTIN (01)40889942580607 EXP (17)2021-01-31 LOT (10)19HBE998
Quantity Affected: 28
Reason for Recall
NaCl 250 mL Bag Inj expired 04/2020 while the kit expiration date was after 04/2020.
Distribution
US Nationwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-10-27
Company
Northfield, IL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 193 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Medline Industries Inc has 27 FDA actions in our database, including 14 recalls and 13 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Medline Industries Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Medline Industries Inc have FDA actions?
Medline Industries Inc has 27 FDA actions in our database, including 14 recalls and 13 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0358-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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