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U.S. Department of Health and Human Services

Class 2 Device Recall Medela Enteral Syringe, Acacia Piston Syringe

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  Class 2 Device Recall Medela Enteral Syringe, Acacia Piston Syringe see related information
Date Initiated by Firm February 13, 2015
Date Posted March 11, 2015
Recall Status1 Terminated 3 on November 09, 2015
Recall Number Z-1262-2015
Recall Event ID 70544
510(K)Number K092986  
Product Classification Syringe, piston - Product Code FMF
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.
Code Information NTL-30 G0556, G0561, G0572, G0585, G0593, G0601, G0610, G0614, G0622, G0634, G0644, G0649, G0653, G0662, G0667, G0672, G0683, G0684, G0685, G0698, G0705, G0708, G0711, G0712, G0714, G0716, G0723, G0719, G0726, G0734, G0744, G0750, G0752, G0760  NTL-60 G0554, G0566, G0578, G0594, G0598, G0612, G0615, G0623, G0626, G0636, G0639, G0650, G0657, G0658, G0659, G0665, G0668, G0670, G0671, G0673, G0679, G0680, G0686, G0687, G0691, G0699, G0703, G0706, G0709, G0715, G0722, G0725, G0729, G0735, G0739, G0741, G0745, G0751, G0756, G0761  TL-INT-60 G0563, G0565, G0577, G0663, G0701, G0710, G0713, G0733, G0737, G0753  INT-60 G0555, G0567, G0575, G0587, G0591, G0603, G0620, G0638, G0640, G0648, G0664, G0690, G0718, G0746  NGF-60 G0550, G0560, G0568, G0576, G0592, G0609, G0628, G0646, G0655, G0675, G0688, G0697, G0707, G0724, G0730, G0728, G0743, G0754
Recalling Firm/
Medela Inc. EF Division
785 Challenger St
Brea CA 92821-2948
For Additional Information Contact
Manufacturer 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.
FDA Determined
Cause 2
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 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.
Quantity in Commerce 1,959,187
Distribution Nationwide Distribution.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = FMF and Original Applicant = ACACIA, INC.