Medline Procedural Kits with Defective Syringes Recalled Worldwide
Medline procedural kits containing defective plastic syringes have been recalled worldwide due to potential leaks and breakage. The affected products include ultrasound catheter insertion and circumcision kits distributed globally.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 devices used in invasive surgical procedures. Although no illnesses or injuries have been reported, the recalled syringes may leak or break during use, creating a risk-of-harm scenario in clinical settings.
Plain-English summary
Medline Industries is recalling three procedural kits containing plastic syringes affected by an FDA Safety Alert issued March 19, 2024. The affected products are the Peripheral Ultrasound Catheter Insertion kit (MNS9865, Lot 2021111050), Circumcision Tray (CIT6715, Lot 2023050590), and OSF SMMC Circumcision Kit (CIT7095, Lot 2023091990).
The syringes in these kits may leak, break, or exhibit other quality defects that could pose a risk to patient health. These kits are used in surgical and procedural settings where syringe malfunction could result in patient complications.
The recalled kits have been distributed worldwide. Affected lot numbers are 2021111050, 2023050590, and 2023091990.
The recalled product
- Product
- Medline procedural kits labeled as: 1) PERIPHERAL ULTRASOUND CATHETER INSERTION, Pack Number MNS9865; 2) CIRCUMCISION TRAY, Pack Number CIT6715; 3) OSF SMMC CIRCUMCISION KIT, Pack Number CIT7095
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
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 (6)
- 1) MNS9865
- Lot Number 2021111050
- 2) CIT6715
- Lot Number 2023050590
- 3) CIT7095
- Lot Number 2023091990
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 27 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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