Medline Convenience kits, labeled as: 1) BLOOD CULTURE COLLECTION KIT, Pack Number BP115; 2) NICU CNTRL LINE BLOOD
Summary
The FDA issued a Class II for Medline Convenience kits, labeled as: 1) BLOOD CULTURE COLLECTION KIT, Pack 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-3059-2024
Action Date
2024-09-18
Status
Ongoing
Category
device
Product Description
Medline Convenience kits, labeled as: 1) BLOOD CULTURE COLLECTION KIT, Pack Number BP115; 2) NICU CNTRL LINE BLOOD DRAW KIT, Pack Number DYLAB1044; 3) NEURO ANGIO PACK, Pack Number DYNDA1431A; 4) BLOOD WITHDRAWAL KIT #2, Pack Number DYNDA1683A; 5) LCPH LAB DRAW KIT , Pack Number DYNDH1641A ; 6) LCPH LAB DRAW KIT , Pack Number DYNDH1641AH; 7) INFUSION CENTER BLOOD DRAW KIT, Pack Number DYNDH1798; 8) BLOOD CULTURE, Pack Number DYNDH1921; 9) BLOOD WITHDRAWAL TRAY, Pack Number DYNDV1588F; 10) BLOOD WITHDRAWAL TRAY , Pack Number DYNDV1588G ; 11) PHLEBECTOMY PK, Pack Number DYNJ84749; 12) ARTHROGRAPH TRAY, Pack Number MNS12670A; 13) BLOOD CULTURE COLLECTION KIT, Pack Number MNS8915; 14) BLOOD CULTURE COLLECTION KIT, Pack Number MNS8915H ; 15) LACERATION TRAY, Pack Number SUT20955
Lot/Code Info: BP115, Lot Number 21BBG338 ; BP115, Lot Number 21CBE353 ; BP115, Lot Number 21CBJ050 ; DYLAB1044, Lot Number 23GBM782 ; DYNDA1431A, Lot Number 2020012890; DYNDA1683A, Lot Number 2019011790; DYNDA1683A, Lot Number 2019032590; DYNDA1683A, Lot Number 2019042390; DYNDA1683A, Lot Number 2019072390; DYNDA1683A, Lot Number 2019090990; DYNDA1683A, Lot Number 2019102390; DYNDA1683A, Lot Number 2019112290; DYNDA1683A, Lot Number 2020030990; DYNDH1641A , Lot Number 21JBE248 ; DYNDH1641A , Lot Number 21JBY828 ; DYNDH1641AH, Lot Number 21JBE248 ; DYNDH1641AH, Lot Number 21JBY828 ; DYNDH1798, Lot Number 2022112990; DYNDH1921, Lot Number 23KBC196; DYNDV1588F, Lot Number 2019022090; DYNDV1588F, Lot Number 2019041890; DYNDV1588F, Lot Number 2019090390; DYNDV1588F, Lot Number 2020012890; DYNDV1588G , Lot Number 22GBL908 ; DYNDV1588G , Lot Number 22HBN586 ; DYNDV1588G , Lot Number 22JBI927 ; DYNDV1588G , Lot Number 22LBK218 ; DYNDV1588G , Lot Number 23ABJ940 ; DYNDV1588G , Lot Number 23EBB512 ; DYNDV1588G , Lot Number 23EBU397 ; DYNDV1588G , Lot Number 23IBU991 ; DYNDV1588G , Lot Number 23KBS797 ; DYNJ84749, Lot Number 23HBE651 ; DYNJ84749, Lot Number 23JBD780 ; MNS12670A, Lot Number 2022112990; MNS8915, Lot Number 21GBS360 ; MNS8915, Lot Number 21HBU417 ; MNS8915, Lot Number 21JBI844 ; MNS8915, Lot Number 21JBY844 ; MNS8915, Lot Number 21LBO003 ; MNS8915, Lot Number 21LBS501 ; MNS8915, Lot Number 22CBY070 ; MNS8915, Lot Number 22HBA169 ; MNS8915, Lot Number 22HBT299 ; MNS8915, Lot Number 22IBR400 ; MNS8915, Lot Number 22KBV233 ; MNS8915, Lot Number 23ABF223 ; MNS8915, Lot Number 23CBT546 ; MNS8915, Lot Number 23DBA141 ; MNS8915, Lot Number 23EBF405 ; MNS8915, Lot Number 23FBF145 ; MNS8915, Lot Number 23GBH740 ; MNS8915, Lot Number 23IBL050 ; MNS8915, Lot Number 23JBK017 ; MNS8915, Lot Number 23LBE535 ; MNS8915, Lot Number 24ABQ710 ; MNS8915H , Lot Number 21GBS360 ; MNS8915H , Lot Number 21HBU417 ; MNS8915H , Lot Number 21JBI844 ; MNS8915H , Lot Number 21JBY844 ; MNS8915H , Lot Number 21LBO003 ; MNS8915H , Lot Number 21LBS501 ; MNS8915H , Lot Number 22CBY070 ; MNS8915H , Lot Number 22HBA169 ; MNS8915H , Lot Number 22HBT299 ; MNS8915H , Lot Number 22IBR400 ; MNS8915H , Lot Number 22KBV233 ; MNS8915H , Lot Number 23ABF223 ; MNS8915H , Lot Number 23CBT546 ; MNS8915H , Lot Number 23DBA141 ; MNS8915H , Lot Number 23EBF405 ; MNS8915H , Lot Number 23FBF145 ; MNS8915H , Lot Number 23GBH740 ; MNS8915H , Lot Number 23IBL050 ; MNS8915H , Lot Number 23JBK017 ; MNS8915H , Lot Number 23LBE535 ; MNS8915H , Lot Number 24ABQ710 ; SUT20955, Lot Number 2020012890
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-3059-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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