Z-2269-2015 Class II Terminated
FDA device recall Z-2269-2015 was initiated by ErgoSafe Products, LLC (DBA) Prism Medical on June 24, 2015 and is designated Class II. Reason for recall: There is a potential the sling loops may not stay attached to the carry bar hooks. The recall status is terminated (terminated April 3, 2017). Affected quantity: 7105 lifts.
Recall Details
- Product Type
- Devices
- Report Date
- August 5, 2015
- Initiation Date
- June 24, 2015
- Termination Date
- April 3, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7105 lifts
Product Description
Prism Medical P-440 Portable Ceiling Lift; PN 303070 and 303070R (refurbished); Patient lift with weight specification of 440 lbs (200 kg). Product Usage: The P-440 lift is a lifting aid used by health care professionals and those providing care in the home to lift, position, and transfer clients or a disabled family member. The ceiling lift makes it possible to move mobility impaired individuals with minimal strain or risk to the caregiver, while providing complete safety, dignity, and comfort for the client or family member.
Reason for Recall
There is a potential the sling loops may not stay attached to the carry bar hooks.
Distribution Pattern
Worldwide Distribution - US Nationwide and the countries of:Canada, Great Britain, Australia, South Korea, and Japan.
Code Information
All serial numbers.