Medline procedural kits labeled as: 1) CIRCUMCISION TRAY, Pack Number CIT6715; 2) NICU CIRCUMCISION TRAY W/OUT CLAM
Summary
The FDA issued a Class II for Medline procedural kits labeled as: 1) CIRCUMCISION TRAY, Pack Number CIT6715 by MEDLINE INDUSTRIES, LP - Northfield. Reason: Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issue.
Details
Source
Device Recall
External ID
Z-2756-2024
Action Date
2024-09-04
Status
Ongoing
Category
device
Product Description
Medline procedural kits labeled as: 1) CIRCUMCISION TRAY, Pack Number CIT6715; 2) NICU CIRCUMCISION TRAY W/OUT CLAMP, Pack Number CIT6920; 3) OSF SMMC CIRCUMCISION KIT, Pack Number CIT7095; 4) RETINAL INJECTION KIT, Pack Number MNS12465; 5) UCLA - BREAST BIOPSY KIT, Pack Number DYNDH1512
Lot/Code Info: CIT6715, Lot Number 2023071390; CIT6920, Lot Number 2021071290; CIT7095, Lot Number 2021071290; CIT7095, Lot Number 2022110390; MNS12465, Lot Number 2023081590; DYNDH1512, Lot Number 2021070790; DYNDH1512, Lot Number 2021080290; DYNDH1512, Lot Number 2022011990; DYNDH1512A, Lot Number 2022110390; DYNDH1512A, Lot Number 2023052290; DYNDH1512A, Lot Number 2023071390; DYNDH1512A, Lot Number 2024022690
Reason for Recall
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
Distribution
Worldwide
Type: Voluntary: Firm initiated
Recall Initiated: 2024-04-08
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 409 device recalls issued in the same week, part of 413 device-related FDA actions this month.
MEDLINE INDUSTRIES, LP - Northfield has 822 FDA actions in our database, including 822 recalls.
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, LP - Northfield) 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, LP - Northfield have FDA actions?
MEDLINE INDUSTRIES, LP - Northfield has 822 FDA actions in our database, including 822 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2756-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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