Medline Convenience kits labeled as: 1) ADMIT KIT , Pack Number DYKA1225B; 2) BRANSON SUPPLEMENTAL PACK , Pack Numb
Summary
The FDA issued a Class II for Medline Convenience kits labeled as: 1) ADMIT KIT , Pack Number DYKA1225B; 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-3038-2024
Action Date
2024-09-18
Status
Ongoing
Category
device
Product Description
Medline Convenience kits labeled as: 1) ADMIT KIT , Pack Number DYKA1225B; 2) BRANSON SUPPLEMENTAL PACK , Pack Number DYNDA3019; 3) L & D PACK-LF , Pack Number DYNJ16121O ; 4) FAMILY PLANNING PACK, Pack Number DYNJ59783C ; 5) NEW LIFE PACK , Pack Number DYNJ69208A ; 6) NEW LIFE PACK , Pack Number DYNJ69208B ; 7) RADIOLOGY PACK, Pack Number DYNJ69603; 8)AMBULATORY MINI PACK, Pack Number DYNJ82579; 9) NURSING SKILLS, Pack Number EDUC1023
Lot/Code Info: DYKA1225B, Lot Number 21GMC515 ; DYNDA3019, Lot Number 23BBO847 ; DYNDA3019, Lot Number 23GBI102 ; DYNDA3019, Lot Number 23HBO766 ; DYNJ16121O , Lot Number 23BBR366 ; DYNJ16121O , Lot Number 23DBR520 ; DYNJ16121O , Lot Number 23FBU745 ; DYNJ16121O , Lot Number 23GBV975 ; DYNJ16121O , Lot Number 23IBR246 ; DYNJ16121O , Lot Number 23LBR806 ; DYNJ16121O , Lot Number 24ABR196 ; DYNJ59783C , Lot Number 21KMF298 ; DYNJ59783C , Lot Number 23FMC164 ; DYNJ69208A , Lot Number 22KBV360 ; DYNJ69208A , Lot Number 23FBE076 ; DYNJ69208B , Lot Number 23IBN578 ; DYNJ69208B , Lot Number 23KBR836 ; DYNJ69603, Lot Number 21HMG219 ; DYNJ69603, Lot Number 21JMI295 ; DYNJ69603, Lot Number 22BMB206 ; DYNJ69603, Lot Number 22GMB031 ; DYNJ69603, Lot Number 22HMA445 ; DYNJ69603, Lot Number 22HMF745 ; DYNJ69603, Lot Number 22IME788 ; DYNJ69603, Lot Number 22JME874 ; DYNJ69603, Lot Number 23EMD691 ; DYNJ69603, Lot Number 23FMA290 ; DYNJ69603, Lot Number 23FMH511 ; DYNJ82579, Lot Number 23LBO804; DYNJ82579, Lot Number 23KBO218; DYNJ82579, Lot Number 23IBM199; DYNJ82579, Lot Number 23GBQ788; DYNJ82579, Lot Number 23EBT027; DYNJ82579, Lot Number 23EBC375; DYNJ82579, Lot Number 23CBP897; DYNJ82579, Lot Number 23BBG331; DYNJ82579, Lot Number 22LBH343; DYNJ82579, Lot Number 22HBQ045; EDUC1023 , Lot Number 22HDA683 ; EDUC1023 , Lot Number 22HDA854
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-3038-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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