Port Kit with Access Infusion Set under the following labels: 1) 8F/SL/Plastic Port/F, Product Number H965450140, Catalo
FDA device recall Z-0826-2014 · posted 2014-01-24 · Terminated
Recall details
- Recalling firm
- Navilyst Medical, Inc.
- Reason for recall
- Navilyst Medical has recalled a Port Kit with Access Infusion Set due to a possible breach of sterilization barrier.
- Action taken
- Navilyst Medical, Inc., sent an Urgent Medical Device Recall - Immediate Action Required letter dated November 25, 2013 to their customers via Federal Express. The letter identified the affected product, problem and actions to be taken. Customers are instructed to segregate and return all affected devices to Navilyst Medical, Inc. Distribution Center Attn: QA Returns 10 Glens Falls Technical Park Glens Falls, NY 12801 and complete and return the Reply Verification Tracking Form provided in the recall notification via Fax to: 1-800-782-1357. For questions call 1-800-833-9973 between 8:30 am and 7:00 pm (EST).
- Root cause
- Device Design
- Status
- Terminated
- Product code
- FPA
- Quantity affected
- 920 Total kits
- Distribution
- US Nationwide Distribution in the states of CA, CT, DC, MA, NJ, NY, PA, MD, VA, WV, NC, GA, FL, TN, OH, MN, MT, IL, MO, NE, OK, TX, NM, and WA.
- Date initiated
- 2013-11-25
- Date posted
- 2014-01-24
- Date terminated
- 2017-03-10
- Location
- Marlborough, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| NMI PORT II CATHETER (K131694) | Navilyst Medical, Inc. | 2013-08-08 |
| NMI PORT (K122767) | Navilyst Medical, Inc. | 2013-04-30 |
| K-SHIELD PORT ACCESS INFUSION SET WITH HIGH PRESSURE TUBING (K100720) | Kawasumi Laboratories, Inc. | 2010-11-18 |