Medline Circumcision Tray Kits Recalled for Defective Syringes
Medline procedural kits containing circumcision trays are being recalled due to plastic syringes affected by an FDA Safety Alert. The syringes have identified leaks and breakage that may pose risks 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: FDA Class II recall of medical syringes with identified quality defects (leaks, breakage) posing potential patient health risks. No illnesses or injuries have been reported; qualifies as High severity under the rubric for risk-of-harm products without reported injury.
Plain-English summary
Medline Industries is recalling procedural kits labeled as CIRCUMCISION TRAY (Pack Number DYNDA2271, Lot Number 2022111490) distributed worldwide. The kits contain plastic syringes affected by an FDA Safety Alert issued on March 19, 2024.
The syringes in these kits have been identified with leaks, breakage, and other quality issues. These defects may pose a risk to patient health, particularly during surgical procedures where the kits are used.
The recalled product
- Product
- Medline procedural kits labeled as: CIRCUMCISION TRAY, Pack Number DYNDA2271
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device — Surgical Kit
- Hazard
- leakage
- breakage
- contamination-risk
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 (2)
- DYNDA2271
- Lot Number 2022111490
Distribution
Distribution scope not specified by the agency.
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