Medline procedure kits labeled as: 1) DELIVERY PACK, Pack Number DYNJ0923016; 2) DELIVERY PACK-LF, Pack Number DYNJ
Summary
The FDA issued a Class II for Medline procedure kits labeled as: 1) DELIVERY PACK, Pack Number DYNJ0923016; 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 issues.
Details
Source
Device Recall
External ID
Z-1446-2025
Action Date
2025-04-02
Status
Ongoing
Category
device
Product Description
Medline procedure kits labeled as: 1) DELIVERY PACK, Pack Number DYNJ0923016; 2) DELIVERY PACK-LF, Pack Number DYNJ0968863M; 3) L & D PACK-LF, Pack Number DYNJ0373290N; 4) L&D PACK, Pack Number DYNJ51998A; 5) LABOR & DELIVERY PACK-LF, Pack Number DYNJ0348455P; 6) LABOR AND DELIVERY TRAY-LF, Pack Number DYNJ23054J; 7) OB DELIVERY-LF, Pack Number DYNJ40096F; 8) VAG DELIVERY PACK, Pack Number DYNJ83056; 9) VAGINAL DELIVERY, Pack Number DYNJ27939D; 10) VAGINAL DELIVERY PACK, Pack Number DYNJ25843C; 11) VAGINAL DELIVERY PACK, Pack Number DYNJ43395; 12) VAGINAL DELIVERY PACK-LF, Pack Number DYNJ0594115L
Lot/Code Info: 1) Pack Number DYNJ0923016: UDI/DI 10889942099634 (each) 40889942099635 (case), Lot Number 23IMF426A; 2) Pack Number DYNJ0968863M: UDI/DI 10889942323081 (each) 40889942323082 (case), Lot Number 21JMG530A; 3) Pack Number DYNJ0373290N: UDI/DI 10193489967371 (each) 40193489967372 (case), Lot Number 21IMH700A; 4) Pack Number DYNJ51998A: UDI/DI 10193489923506 (each) 40193489923507 (case), Lot Number 22IBG256Z; 5) Pack Number DYNJ0348455P: UDI/DI 10195327430481 (each) 40195327430482 (case), Lot Number 23HMC532A; 6) Pack Number DYNJ23054J: UDI/DI 10193489215649 (each) 40193489215640 (case), Lot Number 22CMB444A; 7) Pack Number DYNJ40096F: UDI/DI 10193489923094 (each) 40193489923095 (case), Lot Number 23IMF243A; 8) Pack Number DYNJ83056: UDI/DI 10195327234416 (each) 40195327234417 (case), Lot Number 22JMB827A; 9) Pack Number DYNJ27939D: UDI/DI 10195327148232 (each) 40195327148233 (case), Lot Number 22LBE104A; 10) Pack Number DYNJ25843C: UDI/DI 10889942853731 (each) 40889942853732 (case), Lot Number 21EBN038A; 11) Pack Number DYNJ43395: UDI/DI 10888277049444 (each) 40888277049445 (case), Lot Number 21LMG173A; 12) Pack Number DYNJ0594115L: UDI/DI 10193489382730 (each) 40193489382731 (case), Lot Number 20JKB018A
Quantity Affected: 1958 units
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 - US Nationwide and the country of Canada.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-02-11
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 216 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-1446-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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