Medline Recalls Non-Sterile Laparoscopy CDS Kits Due to Sterilization Error
Medline Industries is recalling 15 kits of Laparoscopy CDS because a non-sterile anti-fog component was not exposed to the sterilization process.
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: The recall involves a medical device where a non-sterile component was released, posing a risk of harm (infection) even though no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Medline Industries, Inc. is recalling 15 kits of Laparoscopy CDS (Model CDS920114F, Lot 17MB5499). The recall was initiated because a non-sterile component, specifically an Anti-fog kit (component #80532NS), was inadvertently included in the pack without being exposed to the ethylene oxide sterilization process.
The affected component, which contains a bottle of 6g Anti-Fog solution and an adhesive-backed sponge, was supposed to be placed in the sterile portion of the pack for sterilization but was not. As a result, the component was released in a non-sterile state despite being labeled as sterile.
The affected products were distributed in California and New Mexico. Consumers and healthcare facilities should stop using the affected kits and contact Medline Industries for further instructions.
The recalled product
- Product
- Laparoscopy CDS
- Manufacturer
- Medline Industries, Inc.
- Category
- Medical Device — Surgical Kits
- 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 (1)
- Model: CDS920114F. Lot: 17MB5499
Distribution
Part of a larger recall action
This product is one of 5 recalled by Medline Industries, Inc. 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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