Z-0589-2019Class II

ARJOHUNTLEIGH GETINGE GROUP Flites Passive Clip Sling -

Name: Z-0589-2019 ARJOHUNTLEIGH GETINGE GROUP Flites Passive Clip Sling -
Creator: ARJOHUNTLEIGH POLSKA Sp. z.o.o.
Published: 2018-10-22
License: https://open.fda.gov/license/

ArjoHuntleigh Polska Sp. zo.o. / initiated 2018-10-22 / Terminated / root cause: manufacturing process

FDA source

ARJOHUNTLEIGH POLSKA Sp. z.o.o. began a recall of ARJOHUNTLEIGH GETINGE GROUP Flites Passive Clip Sling - Product Usage: The Arjo Passive Clip Sling is a product intended for assisted transfer of... on 2018-10-22. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0589-2019
Classification: Class II
Status: Terminated
Initiated: 2018-10-22
Posted: 2018-12-07
Terminated: 2021-05-19
Recalling firm: ArjoHuntleigh Polska Sp. zo.o.
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 with everyday patient handling routines, such as bed and chair related transfers. REF MFA1000M-L-L1 RM0255_7
Product code: FSA Lift, Patient, Non-Ac-Powered
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: On 10/10/2018 the firm informed its US consignee via telephone of an Urgent Medical Device Removal Action. On 11/10/2018, an Urgent Field Safety Notice Letter was sent via United Parcel Services (UPS) to consignees. The firm informed its consignee that according to inspection and test results at the manufacturer, it was found that nonwoven material used in this specific lot of the product might break on the main body while in use during the patient/resident transfer. If the product fails as described, the 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 notification also instructed the consignee to distributed to those individuals who need to be aware within your organization or to any organization where the potentially affected devices have been transferred. Customers were instructed to contact the firm if potentially affected products were found. Customers were also instructed to maintain awareness of this notice and resulting action for an appropriate period to ensure effectiveness of the corrective action. If you have any further questions or require assistance completing the Customer Response Form, please contact Arjo via email at [email protected]. In addition to the notification, a Customer Response Attestation requiring customers to complete the form and return via email to [email protected] or fax to 1-833-fax-arjo.
Quantity in commerce: 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
Product codes and lots: Model - MFA1000M-L-L1 Lot: DHD1301721 UPN 40679252100332

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0589-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0589-2019	Class II	Terminated	Voluntary: Firm initiated	2018-12-19	2018-12-07

Product code FSA

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)