Medline Sterile Medical Kit with Mislabeled Non-sterile Component Recalled
Medline's KIT PEDI CRANI LAMI sterile kits contain a non-sterile Mastisol component not labeled as such, raising infection risk. 485 units were distributed in Texas, Illinois, and California.
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: This is an FDA Class II medical device recall involving a theoretical risk of patient infection with no reported illnesses or injuries. Per the rubric, risk-of-harm products where injury has not been reported score at most 3.
Plain-English summary
Medline Industries is recalling KIT PEDI CRANI LAMI sterile convenience kits due to a labeling defect affecting 485 units distributed in Texas, Illinois, and California.
A Mastisol component within certain kits is non-sterile but was not labeled as being either sterile or non-sterile. Since users typically assume all components within a sterile convenience kit are sterile, the presence of an undeclared non-sterile component creates an increased risk of patient infection.
Affected units can be identified by the following lot numbers: 23ILA372, 23ILA184, 23HLB240, 23HLA567, 23HLA126, 23ELA634, 23DLA974, 23ALA995, 22JLA577, 22HLA985, 22HLA379, 22GLB224, 22GLB099, 22GLA383, 22GLA171, 22DLA615, 22CLA957, 22ALA965, and 22ALA325.
The recalled product
- Product
- KIT PEDI CRANI LAMI, Pack Number DYNJ907372A
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device — Surgical Kit
- Affected units
- 485
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 (20)
- UDI/DI Case 40195327060412
- UDI/DI Each 10195327060411
- Lot Numbers: 23ILA372
- 23ILA184
- 23HLB240
- 23HLA567
- 23HLA126
- 23ELA634
- 23DLA974
- 23ALA995
- 22JLA577
- 22HLA985
- 22HLA379
- 22GLB224
- 22GLB099
- 22GLA383
- 22GLA171
- 22DLA615
- 22CLA957
- 22ALA965
Distribution
Part of a larger recall action
This product is one of 4 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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