American Optisurgical Recalls ChloraPrep Applicators Due to Seal Defect
American Optisurgical is recalling ChloraPrep Hi-Lite Orange 3mL Applicators because an incomplete seal on the packaging may have compromised sterility assurance.
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 with a sterility assurance failure, which poses a risk of harm (infection) even though no specific injuries or illnesses are reported in the source text. This aligns with the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
American Optisurgical, Inc. has initiated a recall of ChloraPrep Hi-Lite Orange 3mL Applicators. The recall was initiated in response to a sub-recall letter from Medline Industries, Inc. The issue involves a lack of sterility assurance caused by an incomplete seal on the individual unit packaging.
The affected product is the FAST Procedure Kit, intended for use as a Minor Surgical Procedures Tray. The recall covers 63 individual applicators. The specific lot numbers affected are 07912-06 and 12912-04.
The product was distributed nationwide in the United States, including the states of AZ, CA, FL, GA, IL, KS, MA, MI, NC, NJ, OH, PA, TN, TX, VA, and WI. Consumers and healthcare providers should check their inventory for these specific lot numbers and stop using the affected applicators.
The recalled product
- Product
- FAST Procedure Kit. Intended for use as a Minor Surgical Procedures Tray.
- Manufacturer
- American Optisurgical Inc
- Affected units
- 63
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)
- Lot Numbers 07912-06 12912-04
Distribution
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