Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported December 19, 2018
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
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/resid…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Arjohuntleigh Polska Sp. z.o.o. recalled ARJOHUNTLEIGH GETINGE GROUP Flites Passive Clip Sling - Product Usage: The Arjo Passive… - a moderate-severity action.
ARJOHUNTLEIGH GETINGE GROUP Flites Passive Clip Sling - Product Usage: The Arjo Passive… was recalled by Arjohuntleigh Polska Sp. z.o.o. in December 19, 2018. Reason: Inspection process at the manufacturer found nonwoven material was used in specific lots of product that may …. Check the official notice for the remedy. Verify recall #Z-0589-2019 with the FDA Devices before acting.
The recall
Arjohuntleigh Polska Sp. z.o.o. issued this moderate-severity FDA Devices recall-Inspection process at the manufacturer found nonwoven material was used in specific lots of product that may ….
- Moderate
- severity level
- 10 units
- affected scope
- Class II
- classification
- December 19, 2018
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0589-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0589-2019) was formally reported on December 19, 2018, with the manufacturer initiating the action on October 22, 2018. It is classified under Moderate severity (Class II), with a current status of Terminated. Arjohuntleigh Polska Sp. z.o.o. is listed as the recalling firm, operating out of Komorniki, N/A. Federal records list the affected scope as 10.
The documented reason for this recall is: 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 consequ… Distribution data in the federal record shows the product reached: US nationwide distribution in the state of WV. OUS: Information not provided due to the product being manufactured OUS and imported to US. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
10
Related Recalls
6
3 from same agency
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
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0589-2019 |
| Date reported | December 19, 2018 |
| Date initiated | October 22, 2018 |
| Recalling firm | Arjohuntleigh Polska Sp. z.o.o. |
| Firm location | Komorniki, N/A |
| Affected scope | 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 |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0589-2019) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Arjohuntleigh Polska Sp. z.o.o.. Units affected: 10.
Why was this product 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 agency issued this recall? ▼
This recall was issued by the FDA Devices on December 19, 2018. Severity: Moderate. Recall number: Z-0589-2019.
Where was the recalled product distributed? ▼
Distribution: US nationwide distribution in the state of WV. OUS: Information not provided due to the product being manufactured OUS and imported to US.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0589-2019) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Nearby Recalls in This Category
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported December 19, 2018. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.