Z-0272-2018 Class II Terminated
FDA device recall Z-0272-2018 was initiated by Stryker Sustainability Solutions on December 1, 2017 and is designated Class II. Reason for recall: 3040 compression sleeves being mislabeled as a 3010-PL compression sleeves. The recall status is terminated (terminated September 27, 2018). Affected quantity: 280 devices.
Recall Details
- Product Type
- Devices
- Report Date
- December 27, 2017
- Initiation Date
- December 1, 2017
- Termination Date
- September 27, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 280 devices
Product Description
3040-VenaFlow Calf Garment (Aircast) Quick Connect was mislabeled as 3010-PL Aircast Pos-Lock Connector. Intended for use in preventing deep vein thrombosis (DVT), diminishing post-operative pain and swelling, enhancing blood circulation and reducing wound healing time on the calf.
Reason for Recall
3040 compression sleeves being mislabeled as a 3010-PL compression sleeves.
Distribution Pattern
Distributed to Texas.
Code Information
Lot 6285035. UDI: 00885825016661.