Medline Convenience kits labeled as: 1) CVC INSERTION PACK, Pack Number CVI4720A ; 2) CVC INSERTION PACK, Pack Numb
Summary
The FDA issued a Class II for Medline Convenience kits labeled as: 1) CVC INSERTION PACK, Pack Number CVI47 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-3010-2024
Action Date
2024-09-18
Status
Ongoing
Category
device
Product Description
Medline Convenience kits labeled as: 1) CVC INSERTION PACK, Pack Number CVI4720A ; 2) CVC INSERTION PACK, Pack Number CVI4720AH; 3) CATHETER INSERTION KIT CLABSI , Pack Number CVI4880; 4) CHEST INSERTION PACK-LF , Pack Number DYNJ17634D ; 5) URETEROSCOPY, Pack Number DYNJ45882A ; 6) TONSIL PACK CATH, Pack Number DYNJ65199A ; 7) CATH PLACEMENT RIB FRACTURE , Pack Number DYNJ66475B ; 8) UROLOGY ROBOTIC PACK, Pack Number DYNJ80211C ; 9) UROLOGY ROBOTIC PACK, Pack Number DYNJ80211CH; 10) UROLOGY PK, Pack Number DYNJ80252C ; 11) PORT INSERTION PACK , Pack Number DYNJ81597
Lot/Code Info: CVI4720A , Lot Number 23DLA715 ; CVI4720A , Lot Number 23ELB184 ; CVI4720A , Lot Number 23GLA187 ; CVI4720A , Lot Number 23ILA599 ; CVI4720A , Lot Number 23ILA949 ; CVI4720A , Lot Number 23JLA318 ; CVI4720A , Lot Number 23JLB102 ; CVI4720AH, Lot Number 23DLA715 ; CVI4720AH, Lot Number 23ELB184 ; CVI4720AH, Lot Number 23GLA187 ; CVI4720AH, Lot Number 23ILA599 ; CVI4720AH, Lot Number 23ILA949 ; CVI4720AH, Lot Number 23JLA318 ; CVI4720AH, Lot Number 23JLB102 ; CVI4880, Lot Number 22LBM567 ; CVI4880, Lot Number 23HBU762 ; DYNJ17634D , Lot Number 23LBB611 ; DYNJ45882A , Lot Number 21HBE710 ; DYNJ45882A , Lot Number 21HBO631 ; DYNJ45882A , Lot Number 21JBD536 ; DYNJ45882A , Lot Number 21VBB891 ; DYNJ45882A , Lot Number 22ABC436 ; DYNJ45882A , Lot Number 19ABG982 ; DYNJ45882A , Lot Number 22CBJ819 ; DYNJ45882A , Lot Number 19BBO164 ; DYNJ45882A , Lot Number 19PBB128 ; DYNJ45882A , Lot Number 19EBS629 ; DYNJ45882A , Lot Number 22GBT307 ; DYNJ45882A , Lot Number 19GBY671 ; DYNJ45882A , Lot Number 19HBJ848 ; DYNJ45882A , Lot Number 19HBZ560 ; DYNJ45882A , Lot Number 22KBA300 ; DYNJ45882A , Lot Number 19IBZ258 ; DYNJ45882A , Lot Number 23ABE331 ; DYNJ45882A , Lot Number 20ABD585 ; DYNJ45882A , Lot Number 23DBJ543 ; DYNJ45882A , Lot Number 20ABG271 ; DYNJ45882A , Lot Number 23FBT108 ; DYNJ45882A , Lot Number 23HBC860 ; DYNJ45882A , Lot Number 20GBJ357 ; DYNJ45882A , Lot Number 20HBL822 ; DYNJ45882A , Lot Number 20IBA668 ; DYNJ45882A , Lot Number 20IBC738 ; DYNJ45882A , Lot Number 20KBE707 ; DYNJ45882A , Lot Number 20KBO720 ; DYNJ45882A , Lot Number 20LBY802 ; DYNJ45882A , Lot Number 21CBX085 ; DYNJ65199A , Lot Number 22CBF155 ; DYNJ65199A , Lot Number 22EME843 ; DYNJ65199A , Lot Number 22EME844 ; DYNJ65199A , Lot Number 23AMH680 ; DYNJ65199A , Lot Number 23DMF610 ; DYNJ65199A , Lot Number 23GMA525 ; DYNJ65199A , Lot Number 23HMA956 ; DYNJ65199A , Lot Number 23HMI132 ; DYNJ66475B , Lot Number 22GBM321 ; DYNJ80211C , Lot Number 23GBJ521 ; DYNJ80211C , Lot Number 23GBT960 ; DYNJ80211C , Lot Number 23HBG313 ; DYNJ80211C , Lot Number 23JBQ875 ; DYNJ80211C , Lot Number 23KBM933 ; DYNJ80211C , Lot Number 23LBP433 ; DYNJ80211CH, Lot Number 23GBJ521 ; DYNJ80211CH, Lot Number 23GBT960 ; DYNJ80211CH, Lot Number 23HBG313 ; DYNJ80211CH, Lot Number 23JBQ875 ; DYNJ80211CH, Lot Number 23KBM933 ; DYNJ80211CH, Lot Number 23LBP433 ; DYNJ80252C , Lot Number 23FBM038 ; DYNJ81597, Lot Number 22IBF254 ; DYNJ81597, Lot Number 23BBO299 ; DYNJ81597, Lot Number 23EBW966 ; DYNJ81597, Lot Number 23JBR560 ; DYNJ81597, Lot Number 24ABD028
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-3010-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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