Medline Convenience kits, labeled as: 1) TRACH CDS-LF , Pack Number CDS983142B ; 2) MER TRACH CDS , Pack Number CD
Summary
The FDA issued a Class II for Medline Convenience kits, labeled as: 1) TRACH CDS-LF , Pack Number CDS98314 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-2982-2024
Action Date
2024-09-18
Status
Ongoing
Category
device
Product Description
Medline Convenience kits, labeled as: 1) TRACH CDS-LF , Pack Number CDS983142B ; 2) MER TRACH CDS , Pack Number CDS984376B ; 3) Flexible LMA Pack with Syringe and Lube, Size 1, Pack Number DYND300010P; 4) Flexible LMA Pack with Syringe and Lube, Size 1.5, Pack Number DYND300015P; 5) Flexible LMA Pack with Syringe and Lube, Size 2, Pack Number DYND300020P; 6) Flexible LMA Pack with Syringe and Lube, Size 2.5, Pack Number DYND300025P; 7) Flexible LMA Pack with Syringe and Lube, Size 3, Pack Number DYND300030P; 8) Flexible LMA Pack with Syringe and Lube, Size 4, Pack Number DYND300040P; 9) Flexible LMA Pack with Syringe and Lube, Size 5, Pack Number DYND300050P; 10) TRACHEOSTOMY TRAY , Pack Number DYNDJ1061A ; 11) TRACHEOSTOMY , Pack Number DYNJ45495F
Lot/Code Info: CDS983142B , Lot Number 19DBQ261 ; CDS983142B , Lot Number 19FBD886 ; CDS983142B , Lot Number 19KBJ083 ; CDS984376B , Lot Number 21HBJ875 ; CDS984376B , Lot Number 21JBJ731 ; CDS984376B , Lot Number 22DBM097 ; CDS984376B , Lot Number 22EBK349 ; CDS984376B , Lot Number 19EBI656 ; CDS984376B , Lot Number 22HBS594 ; CDS984376B , Lot Number 19SBG293 ; CDS984376B , Lot Number 19IBF800 ; CDS984376B , Lot Number 22LBA281 ; CDS984376B , Lot Number 23ABC499 ; CDS984376B , Lot Number 23ABE884 ; CDS984376B , Lot Number 19VBG331 ; CDS984376B , Lot Number 23BBS463 ; CDS984376B , Lot Number 20DBF949 ; CDS984376B , Lot Number 20EBU288 ; CDS984376B , Lot Number 20HBP449 ; CDS984376B , Lot Number 20IBM472 ; CDS984376B , Lot Number 21ABF587 ; DYND300010P, Lot Number 59220061157; DYND300010P, Lot Number 59220122559; DYND300010P, Lot Number 59221040752; DYND300010P, Lot Number 59221071480; DYND300010P, Lot Number 59222030363; DYND300010P, Lot Number 59222051032; DYND300010P, Lot Number 59222061222; DYND300010P, Lot Number 59222040781; DYND300010P, Lot Number 59222040997; DYND300010P, Lot Number 59222071481; DYND300010P, Lot Number 59222071537; DYND300015P, Lot Number 59220061157; DYND300015P, Lot Number 59220122559; DYND300015P, Lot Number 59221040651; DYND300015P, Lot Number 59221050988; DYND300015P, Lot Number 59221091941; DYND300015P, Lot Number 59222051078; DYND300015P, Lot Number 59222051032; DYND300015P, Lot Number 59222081778; DYND300015P, Lot Number 59222081923; DYND300020P, Lot Number 59220061157; DYND300020P, Lot Number 59221030489; DYND300020P, Lot Number 59221061255; DYND300020P, Lot Number 59221102224; DYND300020P, Lot Number 59221112515; DYND300020P, Lot Number 59221122696; DYND300020P, Lot Number 59222040997; DYND300020P, Lot Number 59222051032; DYND300020P, Lot Number 59222061222; DYND300020P, Lot Number 59222071643; DYND300020P, Lot Number 59222081908; DYND300020P, Lot Number 59222040781; DYND300020P, Lot Number 59222071481; DYND300020P, Lot Number 59222081778; DYND300020P, Lot Number 59222081923; DYND300025P, Lot Number 59220061157; DYND300025P, Lot Number 59221030489; DYND300025P, Lot Number 59221061255; DYND300025P, Lot Number 59221071480; DYND300025P, Lot Number 59222051032; DYND300025P, Lot Number 59222061222; DYND300025P, Lot Number 59222081908; DYND300025P, Lot Number 59222081778; DYND300025P, Lot Number 59222081923; DYND300030P, Lot Number 59220061157; DYND300030P, Lot Number 59221020196; DYND300030P, Lot Number 59221030489; DYND300030P, Lot Number 59221040752; DYND300030P, Lot Number 59221081720; DYND300030P, Lot Number 59222010094; DYND300030P, Lot Number 59222010145; DYND300030P, Lot Number 59222030363; DYND300030P, Lot Number 59222040997; DYND300030P, Lot Number 59222040997; DYND300030P, Lot Number 59222040997; DYND300030P, Lot Number 59222051032; DYND300030P, Lot Number 59222061222; DYND300030P, Lot Number 59222071481; DYND300030P, Lot Number 59222071690; DYND300030P, Lot Number 59222081778; DYND300030P, Lot Number 59222081923; DYND300040P, Lot Number 59220061157; DYND300040P, Lot Number 59220122896; DYND300040P, Lot Number 59221030489; DYND300040P, Lot Number 59221050956; DYND300040P, Lot Number 59221061255; DYND300040P, Lot Number 59221061366; DYND300040P, Lot Number 59221071370; DYND300040P, Lot Number 59221071480; DYND300040P, Lot Number 59221071620; DYND300040P, Lot Number 59221050960; DYND300040P, Lot Number 59221061193; DYND300040P, Lot Number 59221081720; DYND300040P, Lot Number 59221102224; DYND300040P, Lot Number 59221112515; DYND300040P, Lot Number 59221112403; DYND300040P, Lot Number 59221122696; DYND300040P, Lot Number 59222030363; DYND300040P, Lot Number 59222051032; DYND300040P, Lot Number 59222051032; DYND300040P, Lot Number 59222051032; DYND300040P, Lot Number 59222051032; DYND300040P, Lot Number 59222061222; DYND300040P, Lot Number 59222040781; DYND300040P, Lot Number 59222040923; DYND300040P, Lot Number 59222071481; DYND300040P, Lot Number 59222071690; DYND300040P, Lot Number 59222081778; DYND300040P, Lot Number 59222081923; DYND300050P, Lot Number 59220061157; DYND300050P, Lot Number 59220122559; DYND300050P, Lot Number 59220122896; DYND300050P, Lot Number 59221030489; DYND300050P, Lot Number 59221061255; DYND300050P, Lot Number 59221071370; DYND300050P, Lot Number 59221050956; DYND300050P, Lot Number 59221050960; DYND300050P, Lot Number 59221112515; DYND300050P, Lot Number 59221112403; DYND300050P, Lot Number 59221122696; DYND300050P, Lot Number 59222040997; DYND300050P, Lot Number 59222040997; DYND300050P, Lot Number 59222040997; DYND300050P, Lot Number 59222040997; DYND300050P, Lot Number 59222051032; DYND300050P, Lot Number 59222061222; DYND300050P, Lot Number 59222040997; DYND300050P, Lot Number 59222071690; DYND300050P, Lot Number 59222081778; DYND300050P, Lot Number 59222081923; DYNDJ1061A , Lot Number 21IBM637 ; DYNDJ1061A , Lot Number 21KBR259 ; DYNDJ1061A , Lot Number 19BBL149 ; DYNDJ1061A , Lot Number 22HBA163 ; DYNDJ1061A , Lot Number 22LBS593 ; DYNDJ1061A , Lot Number 23BBR453 ; DYNDJ1061A , Lot Number 20ABI199 ; DYNDJ1061A , Lot Number 20ABQ477 ; DYNDJ1061A , Lot Number 20BBV927 ; DYNDJ1061A , Lot Number 20CBZ583 ; DYNDJ1061A , Lot Number 23HBA926 ; DYNDJ1061A , Lot Number 23IBU987 ; DYNDJ1061A , Lot Number 23KBF024 ; DYNDJ1061A , Lot Number 23KBI637 ; DYNDJ1061A , Lot Number 20IBH461 ; DYNDJ1061A , Lot Number 20IBH534 ; DYNDJ1061A , Lot Number 20JBU615 ; DYNJ45495F , Lot Number 21DME648
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-2982-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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