Medline Recalls Arthroscopy Kits with Defective Plastic Syringes
Medline Industries is recalling various arthroscopy and arthrogram convenience kits because they contain plastic syringes affected by a March 2024 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 states that quality issues 'may pose a risk to patient health' without reporting specific injuries or illnesses, which aligns with the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Medline Industries, LP is recalling a wide range of medical convenience kits, including arthroscopy, arthrogram, and shoulder arthroscopy packs. The recall is necessary because these kits contain plastic syringes that were identified in an FDA Safety Alert issued on March 19, 2024.
The affected syringes have experienced leaks, breakage, and other quality issues. These defects may pose a risk to patient health during medical procedures. The source text does not specify the number of affected units or report any specific illnesses or injuries.
The affected products 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 the affected kits. Medline Industries is the recalling firm.
The recalled product
- Product
- Medline Convenience kits labeled as: 1) ARTHROGRAPHY DRAPE PACK , Pack Number 00-399027M ; 2) ARTHROSCOPY CDS , Pack Number CDS940242I ; 3) ARTHROSCOPY-LF, Pack Number CDS940859J ; 4) KNEE ARTHROSCOPY CDS-LF , Pack Number CDS940869U ; 5) ARTHROSCOPY CDS , Pack Number CDS940
- 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)
- 00-399027M
- Lot Number 19GLA310
- Lot Number 19KLA520
- Lot Number 19LLA487
- Lot Number 20LLA663
- Lot Number 21JLA024
- Lot Number 21KLA330
- Lot Number 22GLA379
- Lot Number 22HLA991
- Lot Number 23FLA497
- Lot Number 23GLA579
- CDS940242I
- Lot Number 19BBK957
- Lot Number 19KBO521
- Lot Number 20ABP687
- Lot Number 20BBW841
- Lot Number 20EBC100
- Lot Number 20EBD870
- Lot Number 20EBI718
- Lot Number 21BBM845
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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