Centurion Infant Feeding Kit Recalled for Incomplete Sterile Package Seals
Centurion Medical Products Corporation is recalling Infant Feeding Kits due to incomplete seals on the sterile package, which may compromise 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 medical device where a defect may compromise sterility, posing a risk of harm (infection) without reported injuries, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Centurion Medical Products Corporation is recalling 48 units of the Centurion-Infant Feeding Kit (IFK840). The recall is due to incomplete seals on the sterile package, which may compromise the sterility of the product.
The affected product is identified by Lot Code 2019010290. The units were distributed nationwide and to Ghana.
Consumers should stop using the product and contact the recalling firm for instructions on return or replacement.
The recalled product
- Product
- Centurion-Infant Feeding Kit IFK840 INFANT FEEDING KIT (8 FR X 40 IN)
- Manufacturer
- Centurion Medical Products Corporation
- Category
- Medical Device — Infant Feeding
- Affected units
- 48
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 (1)
- Lot Code: 2019010290
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 54 recalled by Centurion Medical Products Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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