FDAClass IIDecember 19, 2018

ARJOHUNTLEIGH GETINGE GROUP Flites Passive Clip Sling recall

ARJOHUNTLEIGH GETINGE GROUP Flites Passive Clip Sling - Product Usage: The Arjo Passive Clip Sling is a product intended for assisted transfer of…

Why was ARJOHUNTLEIGH GETINGE GROUP Flites Passive Clip Sling recalled?

Inspection process at the manufacturer found nonwoven material was used in specific lots of product that may break wile in use during the patient/resident transfer. Patient/resident might fall on the floor. IN consequence, the patient might sustain a major trauma, head injury - damage to tissue that is irreversible or may lead to death.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
ARJOHUNTLEIGH GETINGE GROUP Flites Passive Clip Sling - Product Usage: The Arjo Passive Clip Sling is a product intended for assisted transfer of…
Recalling firm
ARJOHUNTLEIGH POLSKA Sp. z.o.o.
Quantity
10
Distribution
US nationwide distribution in the state of WV. OUS: Information not provided due to the product being manufactured OUS and imported to US
Recall date
December 19, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls