Recall Z-0213-2018 ยท DYB Introducer, Catheter
Sterilmed Inc
St. Jude Medical. Agilis NxT Steerable Introducer: B1-Directional, Medium Curl 22.4 mm, 71 cm, 6.5 F ID; Dilator: 94 cm, 8.5 F; Super Stiff, Guidewire: 180 cm, 0.032". Reprocessed device for single use only, sterile. Product Usage: The reprocessed steerable introducer sheaths are indicated when introducing various cardiovascular catheters into the heart, including the left side of the heart thro
| Date | Dec 29, 2017 (initiated Jun 2, 2017) |
| Status | Terminated |
| Reason | Inadequate seal due to lack of adhesive glue |
| Root cause | Process control |
| Action | Sterilmed sent an Urgent Medical Device Recall letter dated June 12, 2017 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to examine inventory to determine if affected products are on hand, complete and return the Business Reply Form, share information with appropriate staff in facility, attach copy of this notification to quarantined product, and return affected product to Sterilmed. For questions contact Sterilmed's Customer Care Team at 888-541-0078. |
| Quantity | 112 devices |
| Distribution | US Nationwide distribution in the states of AR, CO, FL, MI, OH, TX, and WA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K152090 | Reprocessed Steerable Introducer Sterilmed, Inc., Mar 23, 2016 |