Medline Convenience kits labeled as: 1) URETEROSCOPY CDS SC-LF, Pack Number CDS983922F ; 2) URETEROSCOPY TRAY-RF, P
Summary
The FDA issued a Class II for Medline Convenience kits labeled as: 1) URETEROSCOPY CDS SC-LF, Pack Number C 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-3005-2024
Action Date
2024-09-18
Status
Ongoing
Category
device
Product Description
Medline Convenience kits labeled as: 1) URETEROSCOPY CDS SC-LF, Pack Number CDS983922F ; 2) URETEROSCOPY TRAY-RF, Pack Number DYNJ27442U ; 3) URETHROPLASTY PACK, Pack Number DYNJ39700B ; 4) RRP PACK, Pack Number DYNJ44109B ; 5) PROSTATECTOMY PACK-LF , Pack Number DYNJ66109A ; 6) PERINEAL PACK , Pack Number DYNJ69895; 7) LIVER 2018, Pack Number DYNJ905655A; 8) UROLOGY PACK, Pack Number DYNJT2255M
Lot/Code Info: CDS983922F , Lot Number 19BDC122 ; CDS983922F , Lot Number 19CDC327 ; CDS983922F , Lot Number 19EDB619 ; CDS983922F , Lot Number 19HDB982 ; CDS983922F , Lot Number 19JDA589 ; CDS983922F , Lot Number 19JDC196 ; CDS983922F , Lot Number 20DDB450 ; CDS983922F , Lot Number 20FDB626 ; CDS983922F , Lot Number 20GDA441 ; CDS983922F , Lot Number 20HDA774 ; CDS983922F , Lot Number 20IDA727 ; CDS983922F , Lot Number 20JDC665 ; CDS983922F , Lot Number 21DDB315 ; DYNJ27442U , Lot Number 21HBM391 ; DYNJ27442U , Lot Number 21KBS771 ; DYNJ27442U , Lot Number 21LBY698 ; DYNJ39700B , Lot Number 20CBK667 ; DYNJ39700B , Lot Number 20DBC549 ; DYNJ39700B , Lot Number 20IMA568 ; DYNJ39700B , Lot Number 20KMA519 ; DYNJ39700B , Lot Number 20LME505 ; DYNJ39700B , Lot Number 21DMD882 ; DYNJ39700B , Lot Number 21FMC569 ; DYNJ39700B , Lot Number 21FMF531 ; DYNJ39700B , Lot Number 21GMF302 ; DYNJ39700B , Lot Number 21HMD242 ; DYNJ39700B , Lot Number 21JMH252 ; DYNJ39700B , Lot Number 21KMF491 ; DYNJ39700B , Lot Number 22AMG337 ; DYNJ44109B , Lot Number 21IMF271 ; DYNJ44109B , Lot Number 21JMD783 ; DYNJ44109B , Lot Number 21KME283 ; DYNJ66109A , Lot Number 21JBN809 ; DYNJ66109A , Lot Number 21KBC511 ; DYNJ66109A , Lot Number 22CBP867 ; DYNJ69895, Lot Number 21KBU119 ; DYNJ69895, Lot Number 22EBD392 ; DYNJ69895, Lot Number 22GBH506 ; DYNJ905655A, Lot Number 21ILA013 ; DYNJ905655A, Lot Number 21ILA926 ; DYNJ905655A, Lot Number 21JLB171 ; DYNJ905655A, Lot Number 22ALA375 ; DYNJ905655A, Lot Number 22BLA544 ; DYNJ905655A, Lot Number 22CLB377 ; DYNJ905655A, Lot Number 22ELA391 ; DYNJT2255M , Lot Number 21IMF282 ; DYNJT2255M , Lot Number 21JMC072 ; DYNJT2255M , Lot Number 21JMI117 ; DYNJT2255M , Lot Number 21KMF688 ; DYNJT2255M , Lot Number 21KMG176
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 distribution.
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 257 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-3005-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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