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
Recall
- Recall Number
- Z-0589-2019
- Event Number
- 81562
- Firm
- ARJOHUNTLEIGH POLSKA Sp. z.o.o. Ui. Ks. Piotra Wawrzyniaka 2 Komorniki Poland
- FEI Number
- 3007420694
- Product Code
- FSA
- Status
- Terminated
- Root Cause
- Nonconforming Material/Component
- Initiated
- October 22, 2018
- Terminated
- May 19, 2021
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
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.
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.
US nationwide distribution in the state of WV. OUS: Information not provided due to the product being manufactured OUS and imported to US
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