Medline Convenience Kits with Defective Plastic Syringes Recalled
Medline Industries is recalling multiple medical convenience kits containing plastic syringes with quality defects including leaks and breakage. These defects 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: This is an FDA Class II recall of medical device syringes with identified quality defects (leaks, breakage) that may pose risk to patient health. No injuries or deaths are reported in the source, so per the rubric, a risk-of-harm product without reported injury scores as High (3).
Plain-English summary
Medline Industries, LP is recalling multiple medical convenience kits containing plastic syringes affected by an FDA Safety Alert issued March 19, 2024. The products include stereotactic and ultrasound-guided breast biopsy trays, core biopsy trays, delivery sets, suturing kits, arthrogram trays, blood draw kits, and similar medical convenience kits distributed worldwide. The plastic syringes have identified quality defects including leaks, breakage, and other issues that may pose a risk to patient health. The recall affects multiple product codes and lot numbers spanning distribution dates from 2018 through 2023.
The recalled product
- Product
- Medline Convenience kits labeled as: 1) STEREOTACTIC BREAST BIOPSY TRA, Pack Number BT1095 ; 2) BREAST BIOPSY TRAY, Pack Number MNS5070; 3) BREAST BIOPSY TRAY-LF, Pack Number SPEC0058A; 4) BREAST BIOPSY TRAY, Pack Number DYNDH1142A; 5) BREAST BIOPSY TRAY, Pack Number S
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- syringe-leak
- syringe-breakage
- medical-device-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)
- BT1095
- Lot Number 21HBO851
- Lot Number 21JBA498
- Lot Number 21KBS041
- Lot Number 21LBI316
- Lot Number 22IBE255
- Lot Number 23CBL036
- Lot Number 23DBE633
- Lot Number 21ABU603
- MNS5070
- Lot Number 23LBC489
- Lot Number 23HBL700
- Lot Number 23EBJ365
- SPEC0058A
- Lot Number 2018110290
- DYNDH1142A
- Lot Number 2018120590
- SPEC0130B
- Lot Number 2018121290
- Lot Number 2019012490
Distribution
Distribution scope not specified by the agency.
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