Medline Shoulder CDS convenience kits, REF DYNJ902837D and REF DYNJ902837F, containing expired component NaCl 3000mL Irr
Summary
The FDA issued a Class II for Medline Shoulder CDS convenience kits, REF DYNJ902837D and REF DYNJ902837F, cont by Medline Industries Inc. Reason: The kits may contain an expired component..
Details
Source
Device Recall
External ID
Z-2231-2021
Action Date
2021-08-18
Status
Terminated
Category
device
Product Description
Medline Shoulder CDS convenience kits, REF DYNJ902837D and REF DYNJ902837F, containing expired component NaCl 3000mL Irrigation Bag (exp. date 08/01/2020).
Lot/Code Info: REF DYNJ902837D - Lot 19IBE968, exp. 2020-09-30, GTIN (01)10193489720549; and REF DYNJ902837F - Lot 20LBU450, Exp. 2021-07-31, GTIN (01)10193489357233.
Quantity Affected: 286 kits total for all products
Reason for Recall
The kits may contain an expired component.
Distribution
US Nationwide distribution in the states of MN, NE, and PA.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-07-01
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 183 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-2231-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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