- NTL-30 30ml Nutrio Enteral Feeding Syringe (sterile) - NTL-60 60ml Nutrio Enteral Feeding Syringe (sterile) - TL-INT-6
FDA device recall Z-1262-2015 · posted 2015-03-11 · Terminated
Recall details
- Recalling firm
- Medela Inc. EF Division
- Reason for recall
- 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.
- Action taken
- 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 Customer Service will issue a RMA and schedule a pick-up of the affected product. Contact will be made to ensure product is ready. For further questions please call (888) 399-2455.
- Root cause
- Packaging
- Status
- Terminated
- Product code
- FMF
- Quantity affected
- 1,959,187
- Distribution
- Nationwide Distribution.
- Date initiated
- 2015-02-13
- Date posted
- 2015-03-11
- Date terminated
- 2015-11-09
- Location
- Brea, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ACACIA PISTON SYRINGE (K092986) | Acacia, Inc. | 2009-10-27 |