Medline Procedure kits labeled as: 1) CIRCUMCISION SET, Pack Number CIT6335; 2) CIRCUMCISION TRAY , Pack Number CIT
Summary
The FDA issued a Class II for Medline Procedure kits labeled as: 1) CIRCUMCISION SET, Pack Number CIT6335; 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-2761-2024
Action Date
2024-09-04
Status
Ongoing
Category
device
Product Description
Medline Procedure kits labeled as: 1) CIRCUMCISION SET, Pack Number CIT6335; 2) CIRCUMCISION TRAY , Pack Number CIT6135BH; 3) CIRCUMCISION TRAY , Pack Number CIT2465; 4) CIRCUMCISION TRAY , Pack Number CIT4920; 5) CIRCUMCISION TRAY , Pack Number CIT7455; 6) CIRCUMCISION TRAY , Pack Number DYNDA3045; 7) CIRCUMCISION TRAY , Pack Number DYNDL1889; 8) CIRCUMCISION TRAY , Pack Number CIT7455H ; 9) CIRCUMCISION TRAY W/1.3 CLAMP , Pack Number CIT6075; 10) CIRCUMCISON TRAY, Pack Number CIT7380; 11) HOSPITAL CIRCUMCISION T, Pack Number CIT2825; 12) CIRCUMCISION TRAY , Pack Number CIT6135A ; 13) CIRCUMCISION TRAY , Pack Number CIT6135B ; 14) NICU CIRCUMCISION SET, Pack Number CIT6900;
Lot/Code Info: CIT6335, Lot Number 22IBT528 ; CIT6135BH, Lot Number 22OBI417 ; CIT6135BH, Lot Number 22FBX794 ; CIT6135BH, Lot Number 23CBQ475 ; CIT6135BH, Lot Number 23CBT677 ; CIT6135BH, Lot Number 23EBP345 ; CIT6135BH, Lot Number 23LBI785 ; CIT6135BH, Lot Number 24BBT038 ; CIT2465, Lot Number 21BBH212 ; CIT4920, Lot Number 22GBS036 ; CIT4920, Lot Number 22IBF469 ; CIT4920, Lot Number 23CBG366 ; CIT4920, Lot Number 23IBL492 ; CIT7455, Lot Number 23GBV732 ; DYNDA3045, Lot Number 23FBO420 ; DYNDA3045, Lot Number 23GBI869 ; DYNDA3045, Lot Number 23IBR354 ; DYNDL1889, Lot Number 23GLB117 ; DYNDL1889, Lot Number 23ILA455 ; CIT7455H , Lot Number 23GBV732 ; CIT6075, Lot Number 22DBD285 ; CIT6075, Lot Number 22EBV624 ; CIT6075, Lot Number 23ABM531 ; CIT6075, Lot Number 23CBC554 ; CIT6075, Lot Number 23CBH405 ; CIT6075, Lot Number 23EBC481 ; CIT6075, Lot Number 23EBS480 ; CIT6075, Lot Number 23FBT595 ; CIT6075, Lot Number 23IBT726 ; CIT7380, Lot Number 22GBM440 ; CIT7380, Lot Number 24BBM689 ; CIT2825, Lot Number 22JBI550 ; CIT2825, Lot Number 23BBR929 ; CIT2825, Lot Number 23GBD786 ; CIT2825, Lot Number 23IBL941 ; CIT6135A , Lot Number 21CBG443 ; CIT6135A , Lot Number 21CBG766 ; CIT6135B , Lot Number 22OBI417 ; CIT6135B , Lot Number 22FBX794 ; CIT6135B , Lot Number 23CBQ475 ; CIT6135B , Lot Number 23CBT677 ; CIT6135B , Lot Number 23EBP345 ; CIT6135B , Lot Number 23LBI785 ; CIT6135B , Lot Number 24BBT038 ; CIT6900, Lot Number 21LBB097 ; CIT6900, Lot Number 22GBF169 ; CIT6900, Lot Number 22IBR336 ; CIT6900, Lot Number 23DBE643
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-2761-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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