Centurion Procedure Packs with Defective Syringes Recalled Worldwide
MEDLINE INDUSTRIES is recalling Centurion procedure packs containing syringes with documented leaks, breakage, and other quality defects. The affected syringes may pose a risk to patient health 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: This is an FDA Class II recall of medical syringes with documented quality issues (leaks, breakage) that may pose risk to patients. No illnesses or injuries have been reported in the source documentation, meeting the criterion for high-severity risk-of-harm products where injury has not yet been reported.
Plain-English summary
MEDLINE INDUSTRIES, LP is recalling Centurion procedure packs that contain plastic syringes. The affected products include breast biopsy kits and multiple circumcision kits and trays that were distributed worldwide.
The plastic syringes in these medical procedure packs are affected by quality issues identified in an FDA Safety Alert issued on March 19, 2024. Documented problems include leaks, breakage, and other defects that may pose a risk to patient health during medical procedures.
Multiple lot numbers of Centurion procedure packs manufactured between 2020 and 2024 are included in this recall. Specific lot numbers and product codes are available through the FDA for anyone who may have received or used these products.
The recalled product
- Product
- Centurion procedure packs, containing Caina syringes, labeled as: 1) BREAST BIOPSY KIT, Pack Number DYNDH1512A; 2) CIRCUMCISION KIT, Pack Number CIT6535; 3) CIRCUMCISION KIT, Pack Number CIT7095; 4) CIRCUMCISION TRAY, Pack Number CIT6860A; 5) CIRCUMCISION TRAY, Pack N
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- leakage
- breakage
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)
- DYNDH1512A
- Lot Number 2023030190
- CIT6535
- Lot Number 2023090580
- CIT7095
- Lot Number 2020121190
- Lot Number 2022031590
- CIT6860A
- Lot Number 2021111580
- Lot Number 2022010480
- Lot Number 2022041880
- Lot Number 2022053080
- Lot Number 2022062080
- Lot Number 2022121280
- Lot Number 2023032080
- Lot Number 2023062680
- Lot Number 2023071780
- Lot Number 2023091180
- Lot Number 2023111380
- Lot Number 2024020580
Distribution
Distribution scope not specified by the agency.
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