Medline Convenience kits labeled as: 1) UROLOGY MINOR CDS , Pack Number CDS980371J ; 2) UROLOGY MINOR CDS , Pack Nu
Summary
The FDA issued a Class II for Medline Convenience kits labeled as: 1) UROLOGY MINOR CDS , Pack Number CDS98 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-3047-2024
Action Date
2024-09-18
Status
Ongoing
Category
device
Product Description
Medline Convenience kits labeled as: 1) UROLOGY MINOR CDS , Pack Number CDS980371J ; 2) UROLOGY MINOR CDS , Pack Number CDS980371K ; 3) CIRCUMCISION TRAY 1.1 , Pack Number CIT6260A ; 4) CIRCUMCISION TRAY 1.3 CM BELL , Pack Number CIT7740; 5) CIRCUMCISION TRAY , Pack Number DYNDL1813; 6) CIRCUMCISION PACK , Pack Number DYNJ16826M ; 7) CIRCUMCISION PACK , Pack Number DYNJ16826N ; 8) CIRCUMCISION PACK , Pack Number DYNJ16826O ; 9) CIRCUMCISION PACK , Pack Number DYNJ38941D ; 10) CIRCUMCISION PACK , Pack Number DYNJ38941F ; 11) CIRCUMCISION SJHC-LF, Pack Number DYNJ48471D ; 12) CIRCUMCISION SJHC-LF, Pack Number DYNJ48471F ; 13) CRMC UNIVERSAL PACK-LF, Pack Number DYNJ61119C ; 14) D-CIRCUMCISION PACK , Pack Number DYNJ64432; 15) CIRCUMCISION PACK , Pack Number DYNJ64876A ; 16) CIRCUMCISION PACK , Pack Number DYNJ64876B ; 17) PACK,CIRCUMCISION ASC , Pack Number DYNJ906909A
Lot/Code Info: CDS980371J , Lot Number 19BBJ528 ; CDS980371J , Lot Number 19BBS356 ; CDS980371J , Lot Number 19DBR965 ; CDS980371J , Lot Number 19EBX731 ; CDS980371J , Lot Number 19GBJ926 ; CDS980371J , Lot Number 19HBY831 ; CDS980371J , Lot Number 19IBL323 ; CDS980371K , Lot Number 21GBD850 ; CDS980371K , Lot Number 21HBI925 ; CDS980371K , Lot Number 21JBJ715 ; CDS980371K , Lot Number 19LBF128 ; CDS980371K , Lot Number 20BBU821 ; CDS980371K , Lot Number 20FBB764 ; CDS980371K , Lot Number 20GBR055 ; CDS980371K , Lot Number 20JBT054 ; CDS980371K , Lot Number 20LBC968 ; CDS980371K , Lot Number 21BBE923 ; CDS980371K , Lot Number 21BBG105 ; CDS980371K , Lot Number 21DBL086 ; CIT6260A , Lot Number 22LBQ691 ; CIT6260A , Lot Number 23ABQ560 ; CIT6260A , Lot Number 23EBS513 ; CIT6260A , Lot Number 23HBT731 ; CIT6260A , Lot Number 23LBT432 ; CIT7740, Lot Number 23DBE831 ; CIT7740, Lot Number 23IBR327 ; DYNDL1813, Lot Number 20FBD708 ; DYNJ16826M , Lot Number 20KME235 ; DYNJ16826M , Lot Number 20LMD829 ; DYNJ16826M , Lot Number 20LME603 ; DYNJ16826M , Lot Number 21BMD922 ; DYNJ16826M , Lot Number 21DMC310 ; DYNJ16826M , Lot Number 21GMC003 ; DYNJ16826M , Lot Number 21HMG078 ; DYNJ16826N , Lot Number 21JMF750 ; DYNJ16826N , Lot Number 21LMF895 ; DYNJ16826N , Lot Number 22CMF391 ; DYNJ16826N , Lot Number 22DMG155 ; DYNJ16826N , Lot Number 22FMB133 ; DYNJ16826N , Lot Number 22IMA881 ; DYNJ16826N , Lot Number 22KMF328 ; DYNJ16826N , Lot Number 23AMA622 ; DYNJ16826N , Lot Number 23BMG816 ; DYNJ16826N , Lot Number 23DMA339 ; DYNJ16826O , Lot Number 23FMC064 ; DYNJ16826O , Lot Number 23GMC962 ; DYNJ16826O , Lot Number 23GMG544 ; DYNJ16826O , Lot Number 23HMI663 ; DYNJ16826O , Lot Number 23JMH529 ; DYNJ16826O , Lot Number 24AMA886 ; DYNJ38941D , Lot Number 19BBN390 ; DYNJ38941D , Lot Number 19CBE691 ; DYNJ38941D , Lot Number 19EBK155 ; DYNJ38941D , Lot Number 19FBW883 ; DYNJ38941D , Lot Number 19SBF056 ; DYNJ38941D , Lot Number 19IBO888 ; DYNJ38941D , Lot Number 19KBM786 ; DYNJ38941D , Lot Number 19LBV953 ; DYNJ38941D , Lot Number 20ABG192 ; DYNJ38941D , Lot Number 20CBS685 ; DYNJ38941D , Lot Number 20EBQ929 ; DYNJ38941D , Lot Number 20GBD152 ; DYNJ38941D , Lot Number 20IMA917 ; DYNJ38941D , Lot Number 20JMA465 ; DYNJ38941D , Lot Number 21BMB204 ; DYNJ38941D , Lot Number 21CMC018 ; DYNJ38941D , Lot Number 21CMC276 ; DYNJ38941D , Lot Number 21EMB640 ; DYNJ38941D , Lot Number 21GMA293 ; DYNJ38941D , Lot Number 21HME096 ; DYNJ38941F , Lot Number 21JMF900 ; DYNJ38941F , Lot Number 21JMG634 ; DYNJ38941F , Lot Number 21LMA419 ; DYNJ38941F , Lot Number 21LMB262 ; DYNJ38941F , Lot Number 22AMC764 ; DYNJ38941F , Lot Number 22BMH048 ; DYNJ38941F , Lot Number 22DMB792 ; DYNJ38941F , Lot Number 22EMD006 ; DYNJ38941F , Lot Number 22FMG928 ; DYNJ38941F , Lot Number 22IMA224 ; DYNJ38941F , Lot Number 22KMB540 ; DYNJ38941F , Lot Number 22LMI658 ; DYNJ38941F , Lot Number 22LMI659 ; DYNJ38941F , Lot Number 23BMA793 ; DYNJ38941F , Lot Number 23BMB118 ; DYNJ48471D , Lot Number 21HBN088 ; DYNJ48471D , Lot Number 21HBN097 ; DYNJ48471D , Lot Number 21LBF729 ; DYNJ48471D , Lot Number 22BBN858 ; DYNJ48471D , Lot Number 22FBA176 ; DYNJ48471D , Lot Number 22GBM022 ; DYNJ48471D , Lot Number 22HBR350 ; DYNJ48471D , Lot Number 19HBG760 ; DYNJ48471D , Lot Number 19IBS581 ; DYNJ48471D , Lot Number 19JBH818 ; DYNJ48471D , Lot Number 23FBD447 ; DYNJ48471D , Lot Number 20KBF714 ; DYNJ48471F , Lot Number 23HBB460 ; DYNJ48471F , Lot Number 23KBH955 ; DYNJ48471F , Lot Number 23KBU382 ; DYNJ61119C , Lot Number 20IBT137 ; DYNJ61119C , Lot Number 20WBI854 ; DYNJ61119C , Lot Number 20LBH019 ; DYNJ61119C , Lot Number 21CBN114 ; DYNJ61119C , Lot Number 21FMD836 ; DYNJ61119C , Lot Number 21GME522 ; DYNJ61119C , Lot Number 21HME553 ; DYNJ61119C , Lot Number 21IMD979 ; DYNJ61119C , Lot Number 21JMA125 ; DYNJ61119C , Lot Number 21KMF555 ; DYNJ61119C , Lot Number 21LMG365 ; DYNJ64432, Lot Number 21IDA848 ; DYNJ64432, Lot Number 21KDC323 ; DYNJ64432, Lot Number 22ADA261 ; DYNJ64432, Lot Number 22CDC116 ; DYNJ64432, Lot Number 22DDC463 ; DYNJ64432, Lot Number 22GDA264 ; DYNJ64432, Lot Number 22HDB210 ; DYNJ64432, Lot Number 22JDA234 ; DYNJ64432, Lot Number 22KDA275 ; DYNJ64432, Lot Number 23BDA297 ; DYNJ64432, Lot Number 23DDC249 ; DYNJ64432, Lot Number 23FDB680 ; DYNJ64432, Lot Number 23GDB911 ; DYNJ64432, Lot Number 23IDA043 ; DYNJ64432, Lot Number 23JDC211 ; DYNJ64876A , Lot Number 21GBB289 ; DYNJ64876A , Lot Number 21HBE385 ; DYNJ64876A , Lot Number 21HBQ607 ; DYNJ64876A , Lot Number 21JBK246 ; DYNJ64876A , Lot Number 21JBU656 ; DYNJ64876A , Lot Number 21KBG007 ; DYNJ64876A , Lot Number 21LBQ521 ; DYNJ64876A , Lot Number 21LBW552 ; DYNJ64876A , Lot Number 22CBM771 ; DYNJ64876A , Lot Number 22HBK326 ; DYNJ64876A , Lot Number 22JBF576 ; DYNJ64876A , Lot Number 22KBG724 ; DYNJ64876A , Lot Number 20HBP009 ; DYNJ64876A , Lot Number 20JBD838 ; DYNJ64876A , Lot Number 20JBG527 ; DYNJ64876A , Lot Number 20JBK521 ; DYNJ64876A , Lot Number 20KBN606 ; DYNJ64876A , Lot Number 21ABW616 ; DYNJ64876A , Lot Number 21CBP857 ; DYNJ64876B , Lot Number 22LBN031 ; DYNJ64876B , Lot Number 23GBL751 ; DYNJ64876B , Lot Number 23IBP497 ; DYNJ64876B , Lot Number 23JBG687 ; DYNJ64876B , Lot Number 23KBI407 ; DYNJ64876B , Lot Number 24ABA124 ; DYNJ906909A, Lot Number 23ABE857 ; DYNJ906909A, Lot Number 23DBD597 ; DYNJ906909A, Lot Number 23DBE346 ; DYNJ906909A, Lot Number 23FBK478 ; DYNJ906909A, Lot Number 23GBI807 ; DYNJ906909A, Lot Number 23HBR596 ; DYNJ906909A, Lot Number 23IBC034 ; DYNJ906909A, Lot Number 23KBH128 ; DYNJ906909A, Lot Number 24ABT698
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-3047-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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