Medline Medical Convenience Kits Recalled for Syringe Quality Issues
Medline is recalling medical convenience kits that contain plastic syringes with potential leaks, breakage, and other quality issues that may pose risks 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: This is a Class II recall of medical devices with identified quality defects (leaks and breakage), but no reported injuries, illnesses, or deaths in the source text. According to the rubric, recalls with theoretical risk of harm and no reported incidents score as High (3).
Plain-English summary
Medline Industries is recalling medical convenience kits containing plastic syringes. The affected products include the Knee Arthroscopy kit (Pack Number CDS983874F) and the Hand kit (Pack Number CDS984080F), which have been distributed worldwide.
The syringes in these kits are affected by an FDA Safety Alert issued on March 19, 2024. Quality issues including leaks, breakage, and other defects have been identified that may pose a risk to patient health.
Multiple lot numbers of both products are included in this recall. Healthcare facilities and individuals who have received these kits should verify whether they possess affected lot numbers and seek further guidance from the manufacturer or the FDA.
The recalled product
- Product
- Medline Convenience kits, labeled as: 1) KNEE ARTHROSCOPY CDS-LF , Pack Number CDS983874F ; 2) HAND, Pack Number CDS984080F
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- leakage
- breakage
- manufacturing-defect
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)
- CDS983874F
- Lot Number 19JDA152
- Lot Number 19KDC441
- Lot Number 20ADB656
- Lot Number 20BDC710
- Lot Number 20EDA493
- Lot Number 20FDB761
- Lot Number 20JDC993
- Lot Number 21ADB720
- Lot Number 21DDA797
- Lot Number 21FDB765
- Lot Number 21HDA924
- Lot Number 21KDA957
- Lot Number 22BDA224
- Lot Number 22DDB013
- Lot Number 22GDA535
- Lot Number 22HDC091
- Lot Number 22JDA459
- Lot Number 23ADB076
- Lot Number 23DDA408
Distribution
Distribution scope not specified by the agency.
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