Medline Medical Convenience Kits Recalled Due to Syringe Quality Issues
Medline is recalling specific medical convenience kits because they contain plastic syringes affected by a March 2024 FDA Safety Alert regarding leaks and breakage.
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 states that quality issues 'may pose a risk to patient health' without reporting specific injuries or illnesses, fitting 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, including ureteroscopy, urethroplasty, and prostatectomy packs, due to quality issues with the plastic syringes contained within them. The recall is associated with an FDA Safety Alert issued on March 19, 2024, which identified leaks, breakage, and other quality defects in the syringes.
The affected products are distributed worldwide and include specific pack numbers and lot numbers listed in the recall documentation. The identified defects may pose a risk to patient health. No specific number of affected units or reported injuries is provided in the source text.
Healthcare facilities and consumers should check their inventory for the specific pack numbers and lot numbers listed in the recall notice. If these products are found, they should be removed from use and returned to Medline or the distributor in accordance with the recall instructions.
The recalled product
- Product
- Medline Convenience kits labeled as: 1) URETEROSCOPY CDS SC-LF, Pack Number CDS983922F ; 2) URETEROSCOPY TRAY-RF, Pack Number DYNJ27442U ; 3) URETHROPLASTY PACK, Pack Number DYNJ39700B ; 4) RRP PACK, Pack Number DYNJ44109B ; 5) PROSTATECTOMY PACK-LF , Pack Number DYNJ6
- 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)
- CDS983922F
- Lot Number 19BDC122
- Lot Number 19CDC327
- Lot Number 19EDB619
- Lot Number 19HDB982
- Lot Number 19JDA589
- Lot Number 19JDC196
- Lot Number 20DDB450
- Lot Number 20FDB626
- Lot Number 20GDA441
- Lot Number 20HDA774
- Lot Number 20IDA727
- Lot Number 20JDC665
- Lot Number 21DDB315
- DYNJ27442U
- Lot Number 21HBM391
- Lot Number 21KBS771
- Lot Number 21LBY698
- DYNJ39700B
- Lot Number 20CBK667
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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