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.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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
- Affected units
- 270,311
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 17 recalled by Medline Industries, LP 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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