Recall Z-1262-2015 ยท FMF Syringe, Piston
Medela Inc. EF Division
- NTL-30 30ml Nutrio Enteral Feeding Syringe (sterile) - NTL-60 60ml Nutrio Enteral Feeding Syringe (sterile) - TL-INT-60 60ml Nutrio Enteral Feeding Syringe with Twistlok adapter (sterile) - INT-60 60mL Nutrio Intopo Enteral Feeding Syringe (sterile) - NGF-60 60ml Nutrio GraviFeed Syringe (sterile) The Enteral Syringe consists of a calibrated hollow cylindrical body and movable plunger. At the
| Date | Mar 11, 2015 (initiated Feb 13, 2015) |
| Status | Terminated |
| Reason | The firm is recalling sterile enteral feeding syringes due to determining that the sterility of the affected products may be compromised as a result of a potential breach in packaging. |
| Root cause | Packaging |
| Action | Medela sent a Device Recall letter dated February 13, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Requested Action of Distributors: 1. Stop sale and distribution of product with affected lot numbers. 2. Conduct a physical count and record the data on the Product Inventory Form included with the letter. 3. Return the Product Inventory Form via fax to 800-995-7867 or e-mail it to syringe@medela.com. The firm should contain a contact name and signature. 4. If have the affected product in stock, Medela Custom |
| Quantity | 1,959,187 |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K092986 | ACACIA PISTON SYRINGE Acacia, Inc., Oct 27, 2009 |