Medline Medical Convenience Kits Recalled Due to Plastic Syringe Quality Issues
Medline Industries is recalling medical convenience kits containing plastic syringes affected by an FDA Safety Alert. The syringes have leaks, breakage, or other quality issues that may pose a risk to patient health.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the source text states that quality issues 'may pose a risk to patient health' without reporting specific injuries or illnesses, which aligns with the High severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Medline Industries, LP is recalling specific medical convenience kits that contain plastic syringes affected by an FDA Safety Alert issued on March 19, 2024. The affected products include various chest exploration, plastic surgery, breast, and other procedure kits, identified by specific pack numbers and lot numbers listed in the recall documentation.
The recall is being conducted because leaks, breakage, and other quality issues have been identified in the plastic syringes contained within these kits. These defects may pose a risk to patient health.
The affected kits were distributed worldwide. Healthcare facilities and consumers should check their inventory for the specific pack numbers and lot numbers listed in the official recall notice and stop using any affected kits. For more information, refer to the FDA recall record Z-3016-2024.
The recalled product
- Product
- Medline Convenience kits labeled as: 1) CHEST EXPLORATION CDS , Pack Number CDS920066K ; 2) CHEST EXPLORATION CDS , Pack Number CDS920066L ; 3) PLASTIC SMR CDS-LF, Pack Number CDS980088K ; 4) PLASTICS, Pack Number CDS980200AA; 5) PLASTICS, Pack Number CDS980200Y ; 6) BREAS
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device — Surgical Kits
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- CDS920066K
- Lot Number 19ABM835
- Lot Number 19CBD966
- Lot Number 19DBS028
- CDS920066L
- Lot Number 19FBR839
- Lot Number 20DBM938
- Lot Number 20GBG553
- Lot Number 20IBF930
- Lot Number 20IBL798
- CDS980088K
- Lot Number 19ABF841
- Lot Number 19BBR779
- Lot Number 19CBI036
- Lot Number 19EBY389
- Lot Number 19HBO214
- Lot Number 19HBU649
- Lot Number 19IBX782
- CDS980200AA
- Lot Number 21HBO940
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 81 recalled by MEDLINE INDUSTRIES, LP - Northfield under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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