Arjo Disposable Repositioning Sling Recalled for Trip Hazard Risk
Getinge recalled 46,085 Arjo Disposable Repositioning Sling units because the sling loop straps pose a trip hazard. The affected devices were distributed nationwide to healthcare facilities.
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: FDA Class II medical device with a confirmed trip hazard that poses a risk of patient and caregiver falls and injuries. No injuries have been reported. The score reflects the risk-of-harm classification for products where injury potential exists but has not yet been documented.
Plain-English summary
Getinge Dominican Republic SA is recalling the Arjo Disposable Repositioning Sling, Model AHD001, a medical device used in healthcare settings for patient repositioning and transfers.
The sling loop straps on these devices pose a trip hazard to patients and caregivers.
The recall affects 46,085 units distributed nationwide across 33 states. Affected lot numbers range from DAG1300482 through DFG1300537 and can be verified on the product packaging.
Patients and caregivers should stop using affected devices immediately. Healthcare facilities and individuals with these slings should contact Getinge for instructions on device replacement or return.
The recalled product
- Product
- Arjo Disposable Repositioning Sling, Model AHD001
- Manufacturer
- Getinge Dominican Republic SA
- Hazard
- Affected units
- 46,085
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 (20)
- Model Number AHD001
- Lots DAG1300482
- DAG1300483
- DAG1300484
- DAG1300485
- DAG1300486
- DAG1300487
- DBG1300488
- DBG1300489
- DBG1300490
- DBG1300491
- DBG1300492
- DBG1300493
- DBG1300494
- DBG1300495
- DBG1300496
- DBG1300497
- DBG1300498
- DBG1300499
- DCG1300500
Distribution
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