Medical procedure kits with defective plastic syringes recalled due to quality issues
Medline Industries is recalling Centurion procedure kits due to plastic syringes with defects including leaks and breakage. These defects may compromise patient safety during medical procedures.
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: FDA Class II recall of medical procedure kits with documented defects (leaks, breakage) in plastic syringes. The broad distribution and use in invasive procedures create genuine risk of patient harm, but no illnesses or injuries are reported in the source. This classification reflects the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Medline Industries, LP is recalling Centurion procedure kits due to plastic syringes affected by an FDA Safety Alert issued March 19, 2024. The syringes have been identified with leaks, breakage, and other quality defects that may pose risks to patient health.
The recall affects 39 different types of medical procedure kits distributed worldwide, including kits used for arterial line placement, biopsies, lumbar punctures, chest tube insertion, circumcision, delivery procedures, and various other invasive clinical procedures. Affected lot numbers span from 2018 through 2024.
These defects may compromise the integrity and sterility of procedure kits during clinical use. Healthcare providers should review the complete list of affected lot numbers provided in the FDA recall notice.
The recalled product
- Product
- Centurion procedure kits, labeled as: 1) 6" FEMORAL ARTERIAL LINE KIT- ICU, Pack Number ART245C; 2) ARTERIAL LINE TRAY-NO CATHETER, Pack Number ART1170; 3) ARTHROGRAM/LP/MYELOGRAM TRAY, Pack Number PT220; 4) ARTHROGRAPH TRAY, Pack Number MNS12670A; 5) BIOPSY SKIN/LACER
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device — Procedure Kits
- Hazard
- syringe-leakage
- syringe-breakage
- quality-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)
- ART245C
- Lot Number 2023101990
- ART1170
- Lot Number 2022121990
- Lot Number 2023012790
- Lot Number 2023021590
- PT220
- Lot Number 2021061490
- Lot Number 2022011090
- MNS12670A
- Lot Number 2021060190
- Lot Number 2023022190
- Lot Number 2023101890
- SUT20455
- Lot Number 2023012390
- BT1060
- Lot Number 2020062490
- BT1015
- DYNDH1137C
- Lot Number 2021091490
Distribution
Distribution scope not specified by the agency.
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