Summary
The FDA issued a Class II for Medline CHEST TUBE REORDER NO: DYNJ36762A by Medline Industries Inc.. Reason: Due to a non-sterile component (tape) being place within the sterile portion of the Chest Tube Convenience Kit.
Details
Source
Device Recall
External ID
Z-1683-2022
Action Date
2022-09-14
Status
Ongoing
Category
device
Product Description
Medline CHEST TUBE REORDER NO: DYNJ36762A
Lot/Code Info: Model Number: DYNJ36762A UDI-DI Code (GTIN Insert/GTIN Case / Lot Number: (01)1019348989440/(01)40193489894401 / 21ILA164 (01)1019348989440/(01)40193489894401 / 21ILA986 (01)1019348989440/(01)40193489894401 / 21JLA315 (01)1019348989440/(01)40193489894401 / 21KLA005 (01)1019348989440/(01)40193489894401 / 21KLA162 (01)1019348989440/(01)40193489894401 / 21KLA629
Quantity Affected: 300 kits
Reason for Recall
Due to a non-sterile component (tape) being place within the sterile portion of the Chest Tube Convenience Kit
Distribution
U.S. Nationwide distribution in the state of AL.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-07-21
Company
Laredo, TX
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 134 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-1683-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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