DJO Aircast Sterile Cuff Recall Due to Sterility Concerns
DJO, LLC is recalling 9 units of Aircast REF 3011 sterile cuffs because they may not meet sterility requirements.
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 labeled as sterile that may not meet sterility requirements, posing a risk of infection or harm, which aligns with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
DJO, LLC is recalling 9 units of Aircast REF 3011 - PL RX only VF-PL Sterile Cuff Pkg. (Lot # 418003, Expiration Date: 2020-12-31). The product was distributed domestically in Oklahoma.
The recall was initiated because the product may not meet sterility requirements. Although the product is labeled as sterile, all units do not appear to meet these requirements.
Consumers who possess this product should stop using it and contact DJO, LLC for instructions on return or replacement.
The recalled product
- Product
- Aircast REF 3011 - PL RX only VF-PL Sterile Cuff Pkg., Lot# 418003, Expiration Date: 2020 -12 - 31, Made in Mexico, DJO, LLC.
- Manufacturer
- DJO, LLC
- Hazard
- Affected units
- 9
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 # 418003 UDI: (01)00888912302418
Distribution
Distributed in 1 state:
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