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Recall Observatory FDA recall evidence

Device 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.

Z-1262-2015

February 13, 2015

Class II

Product summary

Firm
Medela Inc. EF Division
Event
Event 70544
Status
Terminated
Classification
Class II
Quantity
1,959,187
Official record key
device-enforcement:Z-1262-2015

Official wording

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.

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

Distribution pattern: Nationwide Distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.