Medela Recalls Sterile Enteral Feeding Syringes Due to Packaging Breach
Medela Inc. is recalling sterile enteral feeding syringes because a potential packaging breach may have compromised their sterility.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a potential breach in the sterility of medical devices, which poses a risk of harm (infection) even though no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Medela Inc. EF Division is recalling specific lots of sterile enteral feeding syringes, including the NTL-30, NTL-60, TL-INT-60, INT-60, and NGF-60 models. The recall was initiated because the firm determined that the sterility of the affected products may be compromised as a result of a potential breach in the packaging.
The affected products were distributed nationwide. The recall covers approximately 1,959,187 units across various lot codes. These syringes are designed for enteral feeding and are considered sterile products.
Consumers and healthcare providers should stop using the affected syringes and contact Medela Inc. for further instructions or a replacement. The primary risk associated with this recall is the potential loss of sterility, which could introduce infection risks if the products are used as intended.
The recalled product
- 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…
- Manufacturer
- Medela Inc. EF Division
- Affected units
- 1,959,187
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- NTL-30 G0556
- G0561
- G0572
- G0585
- G0593
- G0601
- G0610
- G0614
- G0622
- G0634
- G0644
- G0649
- G0653
- G0662
- G0667
- G0672
- G0683
- G0684
- G0685
- G0698
Distribution
Distributed nationwide across the United States.
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