Arjo Flat Dynamic Positioning System Recalled for Sling Clip Breakage Risk
Arjohuntleigh Magog is recalling 3,390 Arjo Flat Dynamic Positioning Systems due to a risk of sling clip breakage during use.
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 risk of harm (sling clip breakage) in a medical device where injury has not yet been reported, which aligns with the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Arjohuntleigh Magog, Inc. is recalling 3,390 units of the Arjo Flat Dynamic Positioning System (DPS). The recall is due to a risk of sling clip breakage while the system is in use. The DPS is designed for resident transfer in homecare settings, nursing homes, and other assisted living centers, and is used in conjunction with passive clip slings. The system can only be utilized if affixed to a ceiling lift or passive floor lift.
The affected units were distributed worldwide, including nationwide in the United States and in Australia, Belgium, Canada, the Czech Republic, France, Italy, and Poland. Specific product codes associated with the recall include LBA1030-xx, LCA80563-xx, LCA81695-xx, KTX01440.xx, LBX05420-xx, LBX1033-xx, and KTS0010.
Consumers and healthcare facilities should stop using the affected Arjo Flat Dynamic Positioning Systems immediately. Users should contact Arjohuntleigh Magog, Inc. for instructions on how to return the product or obtain a replacement.
The recalled product
- Product
- Arjo Flat Dynamic Positioning System (DPS) - Product Usage: used in conjunction with passive clip slings is designed for resident transfer in a homecare setting, at nursing homes and other assisted living centers. Please note that the DPS can be utilized only if affixed to…
- Manufacturer
- Arjohuntleigh Magog, Inc.
- Affected units
- 3,390
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 (7)
- LBA1030-xx
- LCA80563-xx
- LCA81695-xx
- KTX01440.xx
- LBX05420-xx
- LBX1033-xx
- KTS0010
Distribution
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