Recall record at a glance
| Official record | Z-0589-2019 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | ARJOHUNTLEIGH POLSKA Sp. z.o.o. |
| Report date | Dec 19, 2018 |
| Recall initiation date | Oct 22, 2018 |
| Quantity | 10 |
| Location | Komorniki, N/A, Poland |
Official product description
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 with everyday patient handling routines, such as bed and chair related transfers. REF MFA1000M-L-L1 RM0255_7
Why the product was 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.
Distribution information
US nationwide distribution in the state of WV. OUS: Information not provided due to the product being manufactured OUS and imported to US
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Telephone.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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