Recall Z-1612-2023 ยท JOW Sleeve, Limb, Compressible
Stryker Sustainability Solutions
REF 5065, Kendall, Impad Rigid Sole Foot Cover, Regular Pair ,<12", Rx Only Non-Sterile
| Date | May 19, 2023 (initiated Apr 14, 2023) |
| Status | Open, Classified |
| Reason | Through complaint surveillance, it was identified that reprocessed Deep vein thrombosis (DVT) Compression Sleeves may be mislabeled and/or mispackaged. |
| Root cause | Under Investigation by firm |
| Action | On April 14, 2023, Stryker Sustainability Solutions (SSS) issued an "urgent Medical Device Recall" notification via E-Mail. SSS asked consignees to take the following action: 1) Please check your inventory for the devices from the affected lot and remove them from their point of use. Refer to Figure 1 Product Label. 2) Please complete the Urgent Medical Device Recall Business Reply Form (page 3) and indicate if any of the affected product remains in your inventory. Please return this completed form through one of the following methods: a. Email: SSSPFA@stryker.com b. To your Stryker s |
| Quantity | 50 units |
| Distribution | US: WA OUS: None |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K100909 | REPROCESSED COMPRESSION SLEEVES Ascent Healthcare Solutions, Jul 23, 2010 |