The Recall Desk
HighFDA (Devices)·Z-0552-2022·Announced 2022-02-09

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.

What this means for you

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
Hazard
  • improper-storage
  • device-integrity-risk
  • sterility-risk

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

Distributed nationwide across the United States.

Related recalls

Same category