Centurion Medical Products Recalls YNHH Scope Kits Due to Nasal Spray Contamination
Centurion Medical Products Corporation is recalling 644 YNHH Scope Kits because they contain Major Nasal Decongestant Spray. The kits were distributed in Connecticut and Illinois.
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 an unexplained contamination (nasal spray) and is classified as FDA Class II. Per the rubric, risk-of-harm products where injury has not yet been reported are rated High.
Plain-English summary
Centurion Medical Products Corporation is recalling 644 units of the YNHH Scope Kit (Kit Code: MNS10475). The recall is being conducted because the medical device kits contain Major Nasal Decongestant Spray.
The affected products are associated with three specific lot numbers: 2019060750, 2019060450, and 2018110550. The expiration dates for these lots are 08/31/2020 and 05/31/2020. The distribution pattern for these kits is limited to Connecticut and Illinois.
The source text does not specify the exact nature of the defect beyond the presence of the nasal spray, nor does it report any illnesses or injuries. Consumers and healthcare facilities should check their inventory for these specific lot numbers and contact the manufacturer for further instructions.
The recalled product
- Product
- YNHH SCOPE KIT Kit Code: MNS10475
- Manufacturer
- Centurion Medical Products Corporation
- Category
- Medical Device — Surgical Kits
- Affected units
- 644
Distribution
Part of a larger recall action
This product is one of 3 recalled by Centurion Medical Products Corporation 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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