Premier Rotaclone Medical Device Recalled Due to Improper Storage Conditions
Medline Industries is recalling 34 units of the Premier Rotaclone (Lot 696004N116) due to improper storage in temperature-controlled settings instead of required refrigeration. This may affect device performance or safety.
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: This is a Class II device recall. Although no illnesses or injuries have been reported, improper storage of a medical device that requires refrigeration presents a risk of compromised safety or performance, meeting the criteria for 'High' severity: risk-of-harm products where injury has not yet been reported.
Plain-English summary
Medline Industries, LP is recalling 34 units of the Premier Rotaclone, an Rx-only medical device (Model RID696004, Lot 696004N116, expiration date 01/12/2023). The product was stored incorrectly in a temperature-controlled setting instead of the required refrigerated conditions.
Improper storage of a medical device that requires refrigeration may compromise its integrity, sterility, or performance. The affected units were distributed nationwide in California and Massachusetts.
No illnesses or injuries related to this storage issue have been reported.
The recalled product
- Product
- Premier Rotaclone, Rx only
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device
- Affected units
- 34
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 (3)
- Model Number: RID696004
- Lot Number 696004N116
- Expiration Date 01/12/2023
Distribution
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