Medline Procedural Kits Recalled Due to Defective Plastic Syringes
Medline Industries is recalling multiple procedural kits containing defective plastic syringes that may leak or break. The affected kits were distributed worldwide.
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 procedural kits with defective syringes that may leak or break. These are risk-of-harm products used in medical procedures. No illnesses or injuries are reported, keeping the hazard theoretical; however, per the rubric, risk-of-harm products where injury has not yet been reported score High.
Plain-English summary
Medline Industries is recalling medical procedural kits distributed worldwide that contain plastic syringes affected by an FDA Safety Alert issued on March 19, 2024. The recalled kits include Circumcision Trays, a NICU Circumcision Tray, a Retinal Injection Kit, and Breast Biopsy Kits, identified by pack numbers CIT6715, CIT6920, CIT7095, MNS12465, and DYNDH1512, along with DYNDH1512A variants. Specific lot numbers are listed in the FDA recall notice.
The plastic syringes in these kits have been identified with quality issues including leaks and breakage. According to the FDA, these defects may pose a risk to patient health.
Patients and healthcare providers using these kits should discontinue use of affected units immediately. Refer to the FDA recall notice for complete lot number information and guidance on proper handling or replacement.
The recalled product
- Product
- Medline procedural kits labeled as: 1) CIRCUMCISION TRAY, Pack Number CIT6715; 2) NICU CIRCUMCISION TRAY W/OUT CLAMP, Pack Number CIT6920; 3) OSF SMMC CIRCUMCISION KIT, Pack Number CIT7095; 4) RETINAL INJECTION KIT, Pack Number MNS12465; 5) UCLA - BREAST BIOPSY KIT, Pa
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- defective-syringes
- leaks
- 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 (15)
- CIT6715
- Lot Number 2023071390
- CIT6920
- Lot Number 2021071290
- CIT7095
- Lot Number 2022110390
- MNS12465
- Lot Number 2023081590
- DYNDH1512
- Lot Number 2021070790
- Lot Number 2021080290
- Lot Number 2022011990
- DYNDH1512A
- Lot Number 2023052290
- Lot Number 2024022690
Distribution
Distribution scope not specified by the agency.
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