Medline Chest Tube Kit Recalled for Non-Sterile Tape Component
Medline Industries is recalling Chest Tube Convenience Kits due to non-sterile tape included in the sterile portion of the kit, creating a contamination and infection risk.
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 involving sterility compromise of a surgical medical device with confirmed non-sterile component in the sterile field. While no illnesses have been reported, the potential for serious infection from contaminated equipment used in surgical procedures constitutes a high-risk scenario per the rubric.
Plain-English summary
Medline Industries Inc. is recalling its Chest Tube Convenience Kit (Model Number: DYNJ36762A) due to a manufacturing defect that compromises product sterility.
The recall was issued because non-sterile tape was placed within the sterile portion of the kit. This contamination creates a potential infection risk when the kit is used in patient care or surgical procedures.
Approximately 300 kits were distributed nationwide in Alabama. The affected units can be identified by the following lot numbers: 21ILA164, 21ILA986, 21JLA315, 21KLA005, 21KLA162, and 21KLA629.
Healthcare facilities and medical professionals should verify lot numbers of kits in their possession and consult with Medline Industries for guidance on return, replacement, or disposal of affected units.
The recalled product
- Product
- Medline CHEST TUBE REORDER NO: DYNJ36762A
- Manufacturer
- Medline Industries Inc.
- Category
- Medical Device — Surgical
- Affected units
- 300
Distribution
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