CLASS II ONGOING Device recall · Reported 4 Sep 2024 · FDA Enforcement Report

Medline procedural kits labeled as: Baby Care Kit Univ, Pack Number recalled

MEDLINE INDUSTRIES, LP - Northfield is recalling Medline procedural kits labeled as: Baby Care Kit Univ, Pack Number. The recall was initiated on 8 Apr 2024 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesDYKL1025 , Lot Number 21JBA955 ; DYKL1025 , Lot Number 21LBX335 ; DYKL1025 , Lot Number 22BBW368 ; DYKL1025 , Lot Number 22FBT155 ; DYKL1025 , Lot Number 22IBA604 ; DYKL1025 , Lot Number 22JBJ323 ; DYKL1025 , Lot Number 23ABH574 ; DYKL1025 , Lot Number 23ABS213 ; DYKL1025 , Lot Number 23CBT397 ; DYKL1025 , Lot Number 23FBI255 ; DYKL1025 , Lot Number 23GBF800 ; DYKL1025 , Lot Number 23IBN598 ; DYKL1025H, Lot Number 21JBA955 ; DYKL1025H, Lot Number 21LBX335 ; DYKL1025H, Lot Number 22BBW368 ; DYKL1025H, Lot Number 22FBT155 ; DYKL1025H, Lot Number 22IBA604 ; DYKL1025H, Lot Number 22JBJ323 ; DYKL1025H, Lot Number 23ABH574 ; DYKL1025H, Lot Number 23ABS213 ; DYKL1025H, Lot Number 23CBT397 ; DYKL1025H, Lot Number 23FBI255 ; DYKL1025H, Lot Number 23GBF800 ; DYKL1025H, Lot Number 23IBN598

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2740-2024
FDA event ID: 94581
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL
Classification: Class II
Status: Ongoing
Recall initiated: 8 Apr 2024
FDA classified: 28 Aug 2024
Reported: 4 Sep 2024
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Foreign Material
Device type: Other Medical Devices

Timeline

8 Apr 2024	Recall initiated by company
28 Aug 2024	Classified by FDA	+142 days
4 Sep 2024	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.

Product as listed by the FDA

Medline procedural kits labeled as: 1) BABY CARE KIT UNIV, Pack Number DYKL1025; 2) BABY CARE KIT UNIV, Pack Number DYKL1025H

Where it was distributed

Worldwide

Questions about this recall

Is Medline procedural kits labeled as: Baby Care Kit Univ, Pack Number recalled?

Yes. MEDLINE INDUSTRIES, LP - Northfield recalled Medline procedural kits labeled as: Baby Care Kit Univ, Pack Number on 8 Apr 2024. The recall is Class II and its status is Ongoing. Recall number Z-2740-2024.

Why was it recalled?

Which lots are affected?

DYKL1025 , Lot Number 21JBA955 ; DYKL1025 , Lot Number 21LBX335 ; DYKL1025 , Lot Number 22BBW368 ; DYKL1025 , Lot Number 22FBT155 ; DYKL1025 , Lot Number 22IBA604 ; DYKL1025 , Lot Number 22JBJ323 ; DYKL1025 , Lot Number 23ABH574 ; DYKL1025 , Lot Number 23ABS213 ; DYKL1025 , Lot Number 23CBT397 ; DYKL1025 , Lot Number 23FBI255 ; DYKL1025 , Lot Number 23GBF800 ; DYKL1025 , Lot Number 23IBN598 ; DYKL1025H, Lot Number 21JBA955 ; DYKL1025H, Lot Number 21LBX335 ; DYKL1025H, Lot Number 22BBW368 ; DYKL1025H, Lot Number 22FBT155 ; DYKL1025H, Lot Number 22IBA604 ; DYKL1025H, Lot Number 22JBJ323 ; DYKL1025H, Lot Number 23ABH574 ; DYKL1025H, Lot Number 23ABS213 ; DYKL1025H, Lot Number 23CBT397 ; DYKL1025H, Lot Number 23FBI255 ; DYKL1025H, Lot Number 23GBF800 ; DYKL1025H, Lot Number 23IBN598

Where was it sold?

Worldwide

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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1 Oct 2025Device	CLASS I	Medline medical convenience kits labeled as recalled	MEDLINE INDUSTRIES, LP - Northfield	Device Malfunction	6 states
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