The Recall Desk
SevereFDA (Devices)·Z-0589-2019·Announced 2018-12-19

Arjo Passive Clip Sling Recalled for Material Breakage Risk

ArjoHuntleigh is recalling 10 units of Passive Clip Slings because the material may break during patient transfers, posing a risk of falls and serious injury.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The source text explicitly states that the hazard may lead to death and irreversible tissue damage, which aligns with the rubric criteria for a Severe (4) or Critical (5) rating. Given the agency classification is Class II and the text describes potential rather than confirmed fatalities, a score of 4 is appropriate.

Plain-English summary

ArjoHuntleigh Polska Sp. z.o.o. is recalling 10 units of the Flites Passive Clip Sling (Model MFA1000M-L-L1, Lot DHD1301721). The product is intended for the assisted transfer of patients or residents with limited mobility. The recall was initiated after an inspection process at the manufacturer identified that nonwoven material was used in specific lots of the product.

The identified defect presents a risk that the sling may break while in use during a patient or resident transfer. If the sling breaks, the patient or resident might fall to the floor. The source text notes that such a fall could result in major trauma, head injury, irreversible tissue damage, or death.

The affected units were distributed nationwide in the United States, specifically within the state of West Virginia. The product was manufactured outside the United States and imported for distribution. Consumers and healthcare facilities should stop using the affected slings and contact the recalling firm for instructions on return or replacement.

The recalled product

Product
ARJOHUNTLEIGH GETINGE GROUP Flites Passive Clip Sling - Product Usage: The Arjo Passive Clip Sling is a product intended for assisted transfer of patient/resident with limited ability to move. Designed to be used for one patient during hospital stay and assists the caregiver wi
Affected units
10

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)

  • Model - MFA1000M-L-L1 Lot: DHD1301721 UPN 40679252100332

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Same manufacturer · ARJOHUNTLEIGH POLSKA Sp. z.o.o.

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