Surgical Convenience Kits Recalled for Outer Wrapping Sterility Defect
Medline is recalling 1376 surgical convenience kits nationwide due to a packaging defect that compromises the sterility of the outer wrapping. Only the kit contents remain sterile.
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 a sterility and contamination risk for surgical medical devices where injury has not yet been reported, fitting the rubric criterion for risk-of-harm products. No actual infections or injuries have been reported to date.
Plain-English summary
Medline Industries, LP is recalling MEDLINE PREP TRAY surgical convenience kits (Reorder Number DYNDL1643A, Lot #22HMH244) distributed nationwide. The recall affects 1376 units.
The kits contain a perforated bag that does not allow the outside of the kit wrapping to maintain sterility. Only the contents inside the kit wrapping are guaranteed to be sterile, while the outer wrapping is not sterile.
This defect could allow bacterial contamination of the outer wrapping, which may compromise the integrity of the sterile contents if the outer wrapping is breached. Consumers who have purchased these kits should discontinue use and contact their healthcare provider or Medline for replacement or disposal instructions.
The recalled product
- Product
- Surgical convenience kits labeled as: MEDLINE PREP TRAY, Reorder Number DYNDL1643A
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device — Surgical Kits
- Affected units
- 1,376
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 (3)
- Reorder Number DYNDL1643A
- GTIN 40888277287809
- Lot # 22HMH244
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 20 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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