Medline Convenience Kits with Polycarbonate Syringes Recalled for Unapproved Design Changes
Medline Industries is recalling Convenience Kits containing 10mL polycarbonate colored syringes because the products were modified in ways not approved by the FDA. The kits were distributed nationwide and internationally.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class II recall involving medical devices (syringes) with unapproved design modifications. FDA Class II recalls are classified as Severe per the rubric, as they carry potential for serious adverse outcomes despite no reported illnesses being stated in the source.
Plain-English summary
Medline Industries, LP is recalling Medline Convenience Kits containing select SKUs of 10mL polycarbonate colored syringes, including ENSEMBLE GYNECO SCOPIE-LF (DYNJ53744B) and LAVH GRH-LF (DYNJ41792G) models. A total of 270,311 units have been affected.
The products were subject to unapproved design changes that fall outside the scope of the FDA's 510(k) clearance. This means modifications were made to the devices without the required regulatory approval process.
The affected kits were distributed nationwide throughout the United States and internationally to Canada, Panama, and Barbados. The recalled lots are: DYNJ53744B LOT 24ABS765 and DYNJ41792G LOT 24ABT556.
Patients and healthcare providers who have received or are using these kits should stop use and contact Medline Industries for further instructions regarding replacement or return of the affected products.
The recalled product
- Product
- Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ENSEMBLE GYNECO SCOPIE-LF DYNJ53744B LAVH GRH-LF DYNJ41792G
- Manufacturer
- Medline Industries, LP
- Hazard
- unapproved-design-change
Distribution
Distributed nationwide across the United States.