CLASS II Device recall · Reported 19 Dec 2018 · FDA Enforcement Report
Arjohuntleigh Getinge Group Flites Passive Clip Sling recalled
Arjohuntleigh Polska Sp. z.o.o is recalling Arjohuntleigh Getinge Group Flites Passive Clip Sling, distributed nationwide in the US. The recall was initiated on 22 Oct 2018 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0589-2019
- FDA event ID
- 81562
- Recalling firm
- Arjohuntleigh Polska Sp. z.o.o, Komorniki, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 22 Oct 2018
- FDA classified
- 7 Dec 2018
- Reported
- 19 Dec 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Processing Deviation
- Device type
- Other Medical Devices
Timeline
| 22 Oct 2018 | Recall initiated by company | |
| 7 Dec 2018 | Classified by FDA | +46 days |
| 19 Dec 2018 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
The USDA issues these when meat or poultry was produced without proper inspection, or when a step such as cooking or pasteurisation did not meet requirements.
Product as listed by the FDA
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
Where it was distributed
US nationwide distribution in the state of WV. OUS: Information not provided due to the product being manufactured OUS and imported to US
Questions about this recall
Why was it 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.
Which lots are affected?
Model - MFA1000M-L-L1 Lot: DHD1301721 UPN 40679252100332
Where was it sold?
US nationwide distribution in the state of WV. OUS: Information not provided due to the product being manufactured OUS and imported to US
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Arjohuntleigh Polska Sp. z.o.o
All 10| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Arjo Tenor mobile passive patient lift recalled | Arjohuntleigh Polska Sp. z.o.o | Device Malfunction | Nationwide |
| Device | CLASS II | Arjo medical beds recalled by ARJOHUNTLEIGH POLSKA Sp. z.o.o | Arjohuntleigh Polska Sp. z.o.o | Other | 7 states |
| Device | CLASS II | Arjo medical beds recalled by ARJOHUNTLEIGH POLSKA Sp. z.o.o | Arjohuntleigh Polska Sp. z.o.o | Other | 7 states |
| Device | CLASS I | Sara Plus Active Floor Lift recalled by ARJOHUNTLEIGH POLSKA Sp. z.o.o | Arjohuntleigh Polska Sp. z.o.o | Other | Nationwide |
| Device | CLASS II | Arjo Citadel beds originally assembled recalled | Arjohuntleigh Polska Sp. z.o.o | Other | Nationwide |
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