Reported Dec 19, 2018 · Terminated
ARJOHUNTLEIGH GETINGE GROUP Flites Passive Clip Sling - Product Usage: The Arjo Passive Clip Sling is a product…
ARJOHUNTLEIGH POLSKA Sp. z.o.o.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: ARJOHUNTLEIGH POLSKA Sp. z.o.o. · Ui. Ks. Piotra Wawrzyniaka 2 · Komorniki, N/A · N/A
Is this the product you have?
- ARJOHUNTLEIGH GETINGE GROUP Flites
- Passive Clip Sling - Product UsageThe 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
- Lot codes and dates
- Model - MFA1000M-L-L1 LotDHD1301721 UPN 40679252100332
- Amount recalled
- 10
Where it was sold
- Nationwide
- WV
Why it 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.
This product could cause temporary or reversible health problems — stop using it.
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