Medline chest tube insertion tray may contain non-sterile equipment due to breached seal
Medline is recalling certain chest tube insertion trays due to potential sterility loss if the vendor seal is breached. Non-sterile equipment poses a serious risk during invasive medical procedures.
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 an FDA Class II recall involving potential sterility loss in medical devices with no reported illnesses or injuries. Per the rubric, theoretical hazards with risk of harm but no reported injury in Class II recalls score as High (3).
Plain-English summary
Medline Industries is recalling certain chest tube insertion tray convenience kits (REF CHT1165) due to potential sterility compromise. Kits packaged in breather pouches with lot number 323080002 may have open or unsealed vendor seals, which could result in non-sterile product being used.
The affected kits were distributed worldwide, including the United States, Canada, and Panama. Non-sterile equipment used in chest tube insertion procedures poses a serious risk of infection to patients.
Healthcare facilities and providers who have received these kits should verify the lot number and condition of vendor seals before use. Any kits from lot 323080002 with compromised seals should be removed from service.
The recalled product
- Product
- Medline CHEST TUBE INSERTION TRAY ADUL, REF CHT1165; medical procedure convenience kit
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Affected units
- 15
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)
- UDI/DI 40653160273586 (each)
- 10653160273585 (case)
- Lot Numbers: 24ABB506
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 33 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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