Ecolab Recalls Disposable Light Handle Covers Due to Seal Gaps
Ecolab, Inc. is recalling Disposable Light Handle Covers because sterile packaging may contain gaps in the seal, potentially compromising 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 is classified as FDA Class II. The hazard involves a potential breach of sterile packaging for a medical device used in surgical settings, which poses a risk of harm (infection) even though no specific injuries are reported in the source text.
Plain-English summary
Ecolab, Inc. is recalling Disposable Light Handle Covers, Item Number B1-715-65. The recall involves 5,958 cases, with 50 units per case. These single-use devices are intended to be used as a disposable barrier for a surgical lighting system, allowing surgical team members to manually adjust the lighting.
The recall was initiated because the sterile packaging of the disposable light handle cover may contain gaps in the seal of the pouch. This defect could potentially compromise the sterility of the device. The affected products were distributed domestically to Michigan.
Consumers and healthcare facilities should stop using the affected products and contact Ecolab, Inc. for further instructions or a return. The recall covers specific lot numbers listed in the official FDA notice Z-0523-2018.
The recalled product
- Product
- Disposable Light Handle Cover, Item Number B1-715-65. Packaged 1 device inside a peel pouch and sealed. Sealed pouches are packaged 10 each inside a poly liner. 5 rows of 10 pouches are placed in a labeled corrugated mailer box. Product Usage: Intended to be used as a…
- Manufacturer
- Ecolab, Inc.
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)
- Model/Item/Part No. B1-715-65
- Lot Numbers: 14224
- 14225
- 14226
- 14237
- 14238
- 14239
- 14240
- 14255
- 14253
- 14254
- 14252
- 14261
- 14266
- 14260
- 14265
- 14262
- 14279
- 14276
- 14269
Distribution
Distributed in 1 state:
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