Recall Z-1262-2015— Medela Inc. EF Division
Class II · Terminated
Class II FDA medical device recall by Medela Inc. EF Division, initiated 2015-02-13, terminated 2015-11-09. It names one FDA 510(k) clearance: K092986. Product: - 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 tip of the barrel is an oral lock connector. Product is considered sterile.. 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..
- Recalling firm
- Medela Inc. EF Division
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-02-13
- Terminated
- 2015-11-09
- Firm location
- Brea, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
- 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 tip of the barrel is an oral lock connector. Product is considered sterile.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.