Surgical Convenience Kits Recalled Due to Non-Sterile Outer Wrapping
MEDLINE surgical convenience kits are recalled due to a perforated outer bag that prevents the kit's outer wrapping from remaining sterile. Only the contents inside the wrapper are guaranteed 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: FDA Class II recall with no reported illnesses or hospitalizations. This is a risk-of-harm product (surgical kit with compromised sterility), but no injuries have been reported, placing it at the high-risk threshold.
Plain-English summary
MEDLINE INDUSTRIES, LP is recalling MEDLINE PLASTICS/PEDS KIT surgical convenience kits (Reorder Number DYNDA2489, Lot # 22BMH128). The recall affects 480 units distributed nationwide and identified by GTIN 41093489695366.
The kits are being recalled because the outer bag is perforated, preventing the outside of the kit's wrapping from maintaining sterility. The contents inside the kit's wrapping remain sterile, but the outer packaging no longer provides the expected sterile barrier that surrounds the kit.
This product was distributed nationwide. Healthcare facilities and individuals using these kits should stop using them. For information about replacement kits or proper disposal, contact MEDLINE INDUSTRIES, LP.
The recalled product
- Product
- Surgical convenience kits labeled as: MEDLINE PLASTICS/PEDS KIT, Reorder Number DYNDA2489
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Affected units
- 480
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)
- GTIN 41093489695366
- Lot # 22BMH128
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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