Ecolab Camera Arm Drapes Recalled for Potential Sterility Breach
Ecolab is recalling specific lots of Camera Arm Drapes because wrinkles in the packaging seal could compromise the product's sterility.
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 potential breach in the sterility of a medical device, which poses a risk of harm (infection) even though no specific injuries or illnesses are reported in the source text.
Plain-English summary
Ecolab Inc is recalling 88 cases (1,760 individual units) of Camera Arm Drape (Box of 20) products. The affected items are individually sealed in poly-Tyvek pouches and are intended for use exclusively on the Intuitive Surgical Da Vinci Si Robotic system. The specific lots involved are # D180437A and D180567, under item number 420279-03.
The recall was initiated because the pouches of certain lots may have wrinkles along the seal. These wrinkles could create a channel within the seal, which may result in a breach in the sterility of the product. The drapes are designed to function as a physical barrier to prevent cross-contamination in clinical settings.
The affected products were distributed worldwide, including nationwide distribution in the United States and in numerous international countries. Consumers and healthcare facilities should check their inventory for the specific lot numbers listed above and stop using the product if it matches the recalled description.
The recalled product
- Product
- Camera Arm Drape (Box of 20) individually sealed in poly-Tyvek pouches / Rx Sterile / to used exclusively on the Intuitive Surgical Da Vinci Si Robotic system / Distributed by Intuitive Surgical Product Usage: Microtek Medical Equipment Drapes are intended to cover/wrap…
- Manufacturer
- Ecolab Inc
- Category
- Medical Device — Surgical Drapes
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)
- Item 420279-03 Lots # D180437A and D180567
Distribution
Part of a larger recall action
This product is one of 4 recalled by Ecolab 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.
See all 4 products in this recall →Related recalls
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Similar recalls
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