Recall Z-0272-2018 ยท JOW Sleeve, Limb, Compressible
Stryker Sustainability Solutions
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.
| Date | Dec 1, 2017 |
| Status | Terminated |
| Reason | 3040 compression sleeves being mislabeled as a 3010-PL compression sleeves. |
| Root cause | Packaging |
| Action | An Urgent Medical Device Recall letter, dated December 5, 2017, was distributed to customers. The letter described the affected product and stated the reason for the recall, as well as the risk to health. Customers were instructed to discontinue use of the affected device ,and complete and return the recall effectiveness check form. All affected product should be returned per the instructions provided and a credit will be issued. |
| Quantity | 280 devices |
| Distribution | Distributed to Texas. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K012403 | VANGUARD REPROCESSED COMPRESSION GARMENT Vanguard Medical Concepts, Inc., Oct 17, 2001 |