Medline Convenience kits labeled as: 1) STERILE LIDOCAINE SYRINGE PACK, Pack Number DYNDM1076A ; 2) PEDIATRIC EP PA
Summary
The FDA issued a Class II for Medline Convenience kits labeled as: 1) STERILE LIDOCAINE SYRINGE PACK, 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-2986-2024
Action Date
2024-09-18
Status
Ongoing
Category
device
Product Description
Medline Convenience kits labeled as: 1) STERILE LIDOCAINE SYRINGE PACK, Pack Number DYNDM1076A ; 2) PEDIATRIC EP PACK , Pack Number DYNJ45158A ; 3) CARDIAC MINOR-LF, Pack Number DYNJ51939; 4) CARDIAC MINOR SURGICOUNT PACK , Pack Number DYNJ56573; 5) PEDIATRIC EP PACKMHS, Pack Number DYNJ58876A
Lot/Code Info: DYNDM1076A . Lot Number 19CBP748 ; DYNDM1076A . Lot Number 19DBH317 ; DYNDM1076A . Lot Number 19FBT944 ; DYNJ45158A . Lot Number 21KBK059 ; DYNJ45158A . Lot Number 21LBB289 ; DYNJ45158A . Lot Number 19ABZ159 ; DYNJ45158A . Lot Number 22DBS953 ; DYNJ45158A . Lot Number 22GBC899 ; DYNJ45158A . Lot Number 22GBE801 ; DYNJ45158A . Lot Number 19FBG969 ; DYNJ45158A . Lot Number 19FBM779 ; DYNJ45158A . Lot Number 19GBS210 ; DYNJ45158A . Lot Number 19HBS882 ; DYNJ45158A . Lot Number 19IBN282 ; DYNJ45158A . Lot Number 19JBB002 ; DYNJ45158A . Lot Number 23ABR333 ; DYNJ45158A . Lot Number 23CBK931 ; DYNJ45158A . Lot Number 23HBJ279 ; DYNJ45158A . Lot Number 23IBF733 ; DYNJ45158A . Lot Number 20HBR669 ; DYNJ45158A . Lot Number 20HBX586 ; DYNJ45158A . Lot Number 20LBZ104 ; DYNJ45158A . Lot Number 21EBP316 ; DYNJ51939. Lot Number 22CBA086 ; DYNJ51939. Lot Number 19ABY439 ; DYNJ51939. Lot Number 22OBI663 ; DYNJ51939. Lot Number 19HBH583 ; DYNJ51939. Lot Number 19IBU567 ; DYNJ51939. Lot Number 19JBW741 ; DYNJ51939. Lot Number 19JBX646 ; DYNJ51939. Lot Number 20FBT320 ; DYNJ51939. Lot Number 20LBF765 ; DYNJ51939. Lot Number 20LBK574 ; DYNJ56573. Lot Number 19ABN855 ; DYNJ56573. Lot Number 19CBF516 ; DYNJ56573. Lot Number 19EBQ417 ; DYNJ56573. Lot Number 19HBP237 ; DYNJ56573. Lot Number 19UBC593 ; DYNJ56573. Lot Number 19VBA937 ; DYNJ56573. Lot Number 19KBB135 ; DYNJ58876A . Lot Number 20HBW903 ; DYNJ58876A . Lot Number 20IBJ399 ; DYNJ58876A . Lot Number 20IBM299
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-2986-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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